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{ "NCT_ID" : "NCT02813252", "Brief_Title" : "Long-Term Follow-up Study for Patients Previously Treated With JCAR015", "Official_title" : "Long-Term Follow-up Protocol for Subjects Treated With JCAR015", "Conditions" : ["Acute Lymphoblastic Leukemia"], "Interventions" : ["Genetic: JCAR015"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival. #Intervention - GENETIC : JCAR015 - No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.

#Eligibility Criteria: Inclusion criteria: * Patients who have received at least one dose of JCAR015 in a previous treatment protocol. * Patients who have provided informed consent for the long-term follow-up study prior to study participation. Exclusion criteria: * None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05130489", "Brief_Title" : "CAR T Cell Therapy Related Cardiovascular Outcomes", "Official_title" : "Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes", "Conditions" : ["Cardiovascular Diseases", "B-cell Acute Lymphoblastic Leukemia", "B-cell Lymphoma Refractory", "B-cell Lymphoma Recurrent", "Primary Mediastinal Large B-cell Lymphoma (PMBCL)", "Diffuse Large B Cell Lymphoma", "Cardiotoxicity", "Cardiovascular Complication"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy. Detailed Description CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood. This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up. The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.

#Eligibility Criteria: Inclusion Criteria: * Patients with capacity, (aged 16 and older) * Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies Exclusion Criteria: * Patients under 16 years Sex : ALL Ages : - Minimum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03726515", "Brief_Title" : "CART-EGFRvIII + Pembrolizumab in GBM", "Official_title" : "Phase 1 Study of EGFRvIII-Directed CAR T Cells Combined With PD-1 Inhibition in Patients With Newly Diagnosed, MGMT-Unmethylated Glioblastoma", "Conditions" : ["Glioblastoma"], "Interventions" : ["Biological: Pembrolizumab", "Biological: CART-EGFRvIII T cells"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, phase 1 study to assess the safety and tolerability of EGFRvIII T cells in combination with pembrolizumab (PD-1 Inhibitor) in patients with newly diagnosed, EGFRvIII+, MGMT-unmethylated glioblastoma. #Intervention - BIOLOGICAL : CART-EGFRvIII T cells - autologous T cells that have been engineered to express an extracellular Humanized single chain antibody (scFv) with specificity for EGFRvIII linked to an intracellular signaling molecule comprised of a tandem signaling domain of the 4-1BB and TCRζ signaling modules. - BIOLOGICAL : Pembrolizumab - humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. - Other Names : - Keytruda

#Eligibility Criteria: Inclusion Criteria: * One of the following diagnoses of GBM: a. Newly diagnosed glioblastoma multiforme that is histologically confirmed by pathology review of surgically resected tissue; OR b. An integrated molecular/pathologic diagnosis of diffuse astrocytic glioma, IDH-wildtype, with molecular features of glioblastoma, WHO grade IV. This diagnosis requires patients have one of the following: i. High-level amplification of EGFR; OR ii. Combined whole chromosome 7 gain and whole chromosome 10 loss (+7/-10); OR iii. TERT promoter mutation. * Undergone tumor resection. * No prior systemic therapies, radiation, tumor-treating fields, or intratumoral therapeutic agents including Gliadel wafers are allowed. Tumor resection must be the only tumor-directed treatment that the patient has received for glioboblastoma. * Tumor tissue is positive for EGFRvIII expression, as performed by either the University of Pennsylvania's in-house fusion transcript panel (RNA-based assay using Illumina HiSeq platform) or NeoGenomics Laboratories (quantitative RT-PCR assay). * Tumor tissue is negative for MGMT promoter methylation (i.e. the tumor is MGMT-unmethylated), as performed by either the University of Pennsylvania's in-house pyrosequencing protocol or NeoGenomics Laboratories. * Patients >= 18 years * ECOG performance status 0 <= age <= 1 * Provides written informed consent * Must have adequate organ function as measured by: 1. White blood count >= 2500/mm3; platelets >= 100,000/mm3, hemoglobin >= 9.0 g/dL; without transfusion or growth factor support 2. AST, ALT, LDH, alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin <= 2.0 mg/dL 3. Serum creatinine < 1.5 x upper limit of normal 4. Adequate cardiac function (LVEF >= 45%) * Subjects of reproductive potential must agree to use acceptable birth control methods. Exclusion Criteria: * Pregnant or lactating women * Inadequate venous access for or contraindications to leukapheresis. * Active Hepatitis B, hepatitis C, or HIV infection, or other active, uncontrolled infection * History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) * History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may post an increased risk of serious infusion reactions. * Requirement for immunosuppressive agents including but not limited to cyclosporine, MMF, tacrolimus, rapamycin, or anti-TNF agents within 4 weeks of eligibility confirmation by the physician-investigator. * Subjects with a history of known or suspected, severe or uncontrolled autoimmune or connective tissue disease. Patients with vitiligo, controlled type 1 diabetes mellitus (on stable insulin dose), residual autoimmune-related hypothyroidism (due to autoimmune condition only requiring hormone replacement), or psoriasis (not requiring systemic treatment), or conditions not expected to recur in the absence of an external trigger, are permitted to enroll. * Known history or current interstitial lung disease or non-infectious pneumonitis * Prior allogenic bone marrow or solid organ transplant * Any uncontrolled active medical or psychiatric disorder that would preclude participation as outlined. * Severe, active co-morbidity in the opinion of the physician-investigator would preclude participation in this study, including but not limited to the following: * Unstable angina within 6 months prior to eligibility confirmation by the physician-investigator * Transmural myocardial infarction within the last 6 months prior to eligibility confirmation by the physician-investigator * New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to eligibility confirmation by the physician-investigator. * Serious and inadequately controlled cardiac arrhythmia * Serious or non-healing wound, ulcer, or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to eligibility confirmation by the physician-investigator, with the exception of the craniotomy for tumor resection. 13. Patients with tumors primarily localized to the brain stem or spinal cord. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04938115", "Brief_Title" : "Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia", "Official_title" : "Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells", "Conditions" : ["Leukemia, T Cell"], "Interventions" : ["Biological: CD7 CART"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL Detailed Description The CARs consist of an anti-CD7 VHHs, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy. The Main research objectives: To evaluate the safety and efficacy of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL The Secondary research objectives: To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL #Intervention - BIOLOGICAL : CD7 CART - Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of refractory or relapsed CD7+ acute myeloid leukemia or mixed lineage leukemia was made according to the NCCN 2019.V2 guideline. Refractory AML is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed AML is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patient diagnosed with AML should be treated and whose disease failed with at least 2 prior lines of therapies. Patients whose tumor burden >=5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible; * CD7+ expression on tumor cells (CD7 positive blasts >=50% by flow cytometry); * Life expectancy greater than 12 weeks; * KPS or Lansky score>=60; * HGB>=70g/L (can be transfused); * oxygen saturation of blood>90%; * Total bilirubin (TBil)<=3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 5×upper limit of normal; * Informed consent explained to, understood by and signed by patient/guardian Exclusion Criteria: * Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment); * Has an active GvHD; * Has a history of severe pulmonary function damaging; * With other tumors which is/are in advanced malignant and has/have systemic metastasis; * Severe or persistent infection that cannot be effectively controlled； * Merging severe autoimmune diseases or immunodeficiency disease; * Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]); * Patients with HIV infection or syphilis infection; * Has a history of serious allergies on Biological products (including antibiotics); * Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6; * Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.; * Have received transplant treatment for less than 6 months in prior to enrollment; * Being pregnant and lactating or having pregnancy within 12 months; * Any situations that the researchers believe will increase the risks for the subject or affect the results of the study Sex : ALL Ages : - Minimum Age : 2 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01865617", "Brief_Title" : "Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia", "Official_title" : "Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia/Lymphoma and Non-Hodgkin Lymphoma With Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor", "Conditions" : ["CD19-Positive Neoplastic Cells Present", "Recurrent Adult Acute Lymphoblastic Leukemia", "Recurrent Chronic Lymphocytic Leukemia", "Recurrent Diffuse Large B-Cell Lymphoma", "Recurrent Mantle Cell Lymphoma", "Recurrent Non-Hodgkin Lymphoma", "Recurrent Small Lymphocytic Lymphoma", "Refractory Acute Lymphoblastic Leukemia", "Refractory Chronic Lymphocytic Leukemia", "Refractory Diffuse Large B-Cell Lymphoma", "Refractory Mantle Cell Lymphoma", "Refractory Non-Hodgkin Lymphoma", "Refractory Small Lymphocytic Lymphoma"], "Interventions" : ["Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I/II trial studies the side effects and best dose of laboratory treated T cells to see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin lymphoma, or acute lymphoblastic leukemia that have come back or have not responded to treatment. T cells that are treated in the laboratory before being given back to the patient may make the body build an immune response to kill cancer cells. Detailed Description PRIMARY OBJECTIVES: I. To evaluate the feasibility and safety of adoptive T cell therapy using ex vivo expanded autologous CD8 positive (+) and CD4+ CD19 chimeric antigen receptor (CAR)-T cells for patients with advanced CD19+ B cell malignancies. SECONDARY OBJECTIVES: I. To determine the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells. II. To determine if adoptively transferred T cells traffic to the bone marrow and function in vivo. III. To determine if the adoptive transfer of CD19 CAR-T cells results in depletion of CD19+ B cells in vivo as a surrogate for functional activity. IV. To determine if the adoptive transfer of CD19 CAR-T cells has antitumor activity in patients with measurable tumor burden prior to T cell transfer. V. To determine if the adoptive transfer of CD19 CAR-T cells is associated with tumor lysis syndrome. OUTLINE: This is a phase I, dose-escalation study of autologous CD19 CAR T-cells followed by a phase II study. Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells intravenously (IV) over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity. DOSE DENSE EXPANSION COHORT: An additional cohort will receive a second anti-CD19-CAR lentiviral vector-transduced autologous T cell infusion without additional lymphodepleting chemotherapy 10-21 days after the first infusion if adequate CD19 CAR-T cells can be produced and appropriate criteria are met. After completion of study treatment, patients are followed up for at least 15 years. #Intervention - BIOLOGICAL : Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes - Given IV

#Eligibility Criteria: Inclusion Criteria: INCLUSIONS FOR SCREENING AND LEUKAPHERESIS * Patients with CD19 expressing acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL) * Ability to understand and provide informed consent * Not human immunodeficiency virus (HIV) infected INCLUSIONS FOR CAR-T CELL THERAPY * Patients with: * CLL who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody or who were not eligible for such therapy; patients with CLL for whom ibrutinib is now standard first line therapy, must have progressed on ibrutinib; patients with fludarabine refractory disease are eligible; patients may be treated following allogeneic hematopoietic cell transplant (HCT); for the concurrent ibrutinib cohort, patients must agree to continue on or be restarted on ibrutinib and must not have had prior intolerance to ibrutinib that would prevent this; patients managed with prior dose reductions for toxicity will continue at the reduced dose for the remainder of this study * Indolent NHL or mantle cell NHL who are beyond first remission and previously treated with chemoimmunotherapy or who were not eligible for such therapy; patients who have relapsed following autologous or allogeneic HCT are eligible * Aggressive NHL such as diffuse large B-cell lymphoma (DLBCL), who have relapsed or have residual disease following treatment with curative intent; patients should have relapsed following, or not be eligible for high-dose therapy and autologous HCT; patients with chemotherapy refractory disease or marrow involvement or comorbidities precluding successful autologous HCT are eligible; patients may be treated following allogeneic HCT * Patients with CD19 expressing, relapsed or refractory ALL * Patients with one of the above diagnoses whose disease state does not qualify but who have prognostic indicators that suggest a high risk of progression of disease may be screened and undergo leukapheresis; enrollment for T cell therapy would require meeting the full disease state eligibility * Confirmation of diagnosis * Evidence of CD19 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen or high likelihood of CD19 expression based on disease histology * Karnofsky performance status >= 60% * All patients of childbearing potential must be willing to use a contraceptive method before, during, and for at least two months after the T cell infusion * Ability to understand and provide informed consent Exclusion Criteria: EXCLUSIONS FOR CAR-T CELL THERAPY * Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable * Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the Principal Investigator (PI) * Serum creatinine > 2.5 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) > 5 x upper limit of normal * Bilirubin > 3.0 mg/dL * Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with a forced expiratory volume in one second (FEV1) of < 50 % of predicted will be excluded * Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% will be excluded * Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35% * Uncontrolled active infection Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03068416", "Brief_Title" : "CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy", "Official_title" : "CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy - a Phase II Trial.", "Conditions" : ["B-cell Leukemia", "B-Cell Lymphoma"], "Interventions" : ["Biological: CAR T cells"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. Detailed Description Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After the second infusion patients will be subjected to immunomodulatory treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy. Primary outcome: - Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events. Weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months. Secondary outcome: Tumor response, CAR T cell persistence and immunological profile * Determination of tumor size and the tumor marker CD19. * Determination of the levels of circulating B cells. * Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies. * Determination of activation markers on CAR T cells such as CD107a. * Determination of the presence of immunological markers in blood and biopsies. At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months. #Intervention - BIOLOGICAL : CAR T cells - Autologous CD19-targeting, 3rd generation CAR T cells

#Eligibility Criteria: Inclusion Criteria: * Relapsed or refractory CD19+ B-cell lymphoma or leukemia with no other curative treatment option available. * Measurable disease. * All ages * Performance status ECOG 0 <= age <= 2. * Fertile females/males must consent to use contraceptives during participation of the trial. * Signed informed consent. Exclusion Criteria: * Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. * Patients with primary CNS lymphoma. * Known human immunodeficiency virus (HIV) infection. * Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. * Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient to perform the treatment. * Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest. * Pregnancy * Patients that do not consent to that tissue and blood samples are stored in a biobank * Patients whose cells cannot be manufactured. Sex : ALL Ages : - Minimum Age : 0 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02976857", "Brief_Title" : "A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects", "Official_title" : "A Phase 1 Single Center, Non-randomized Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Refractory Diffuse Large B-cell Lymphoma", "Conditions" : ["Refractory Diffuse Large B-Cell Lymphoma"], "Interventions" : ["Biological: C-CAR-011"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL Detailed Description The 3x3 dose escalation design will be adopted in order to determine the maximum tolerated dose (MTD). Subjects will be enrolled into low-dose group, medium-dose group and high-dose group as below: Dose CAR+ cells/kg Low 0.8×106 Medium 2.5×106 High 5.0×106 DLT is evaluated within 30 days post C-CAR011 infusion). #Intervention - BIOLOGICAL : C-CAR-011 - lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene. - Other Names : - CAR-CD19

#Eligibility Criteria: Inclusion Criteria: * Histologically diagnosed as DLBCL according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (3rd edition 2016) * Refractory DLBCL * All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2016 Version 3) * At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor >= 1.5 cm) * Age 18 <= age <= 70 years, male or female * Expected survival >= 12 weeks * ECOG score 0 <= age <= 1 * Subject's left ventricular ejection fraction (LVEF) is >= 50% and no evidence of pericardial effusion as determined by an ECHO * At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments) * No contraindications of peripheral blood apheresis * Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial measures * Volunteered to participate in this study and signed informed consent Exclusion Criteria: * Have a history of allergy to cellular products * Used any genetically modified T cell therapy * History of allogeneic hematopoietic stem cell transplantation * Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis allowed) or currently receiving intravenous antibiotic therapy and received intravenous antibiotic therapy within one week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible * Hepatitis B or hepatitis C virus infection (including carriers), as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons * Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications * A history of QT prolongation * A history of epilepsy or other central nervous system disorders * The patient had a history of other primary cancers, with the following exceptions: Excisional non-melanoma such as cutaneous basal cell carcinoma; Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer * Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy * Used of systemic steroids within two weeks (using inhaled steroids is an exception) * Women who are pregnant or lactating or have breeding intent in 6 months * Participated in any other clinical trial within three months * The investigators believe that any increase in the risk of the subject or interference with the results of the trial Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03310619", "Brief_Title" : "A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies", "Official_title" : "An Exploratory Phase 1/2 Trial To Evaluate The Safety And Efficacy Of JCAR017 Combinations In Subjects With Relapsed/Refractory B-Cell Malignancies (PLATFORM)", "Conditions" : ["Lymphoma, Non-Hodgkin", "Lymphoma, Large B-Cell, Diffuse", "Lymphoma, Follicular"], "Interventions" : ["Drug: Durvalumab", "Drug: CC-122", "Drug: CC-220", "Drug: Relatlimab", "Biological: JCAR017", "Drug: Ibrutinib", "Drug: CC-99282", "Drug: Nivolumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1/2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested: Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Arm E: JCAR017 in combination with relatlimab and/or nivolumab Arm F: JCAR017 in combination with CC-99282 Additional arms will be added by way of amendment once combination agents have been selected. The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms. Detailed Description During Phase 1, different arms may be opened to test JCAR017 in combination with combination agent(s) in adult subjects with R/R aggressive B-cell NHL. Within each arm, different doses and schedules of JCAR017 and the combination agent(s) may be tested in several cohorts and subcohorts per arm. During Phase 2 of the study, the expansion of any dose level and schedule for any arm that has been shown to be safe may occur. Arm A will test JCAR017 in combination with Durvalumab Arm B will test JCAR017 in combination with CC-122 Arm C will test JCAR017 in combination with CC-220 (iberdomide ) Arm D will test JCAR017 in combination with ibrutinib. Arm E will test JCAR017 in combination with relatlimab and/or nivolumab Arm F will test JCAR017 in combination with CC-99282 All subjects from Phase 1 and Phase 2 will be followed for 24 months following JCAR017 infusion. Post-study follow-up for survival, relapse, long-term toxicity (including new malignancies), and viral vector safety will continue under a separate long-term follow-up (LTFU) protocol for up to 15 years after the JCAR017 dose as per health authority regulatory guidelines. #Intervention - BIOLOGICAL : JCAR017 - Gene modified autologous T cells - DRUG : Durvalumab - Anti-PD-L1 - Other Names : - MEDI4736 - DRUG : CC-122 - Pleiotropic Pathway Modifier - DRUG : Ibrutinib - Ibrutinib - DRUG : CC-220 - CC-220 - DRUG : Relatlimab - Relatlimab - DRUG : Nivolumab - Nivolumab - DRUG : CC-99282 - CC-99282

#Eligibility Criteria: Inclusion Criteria: * Subject is >= 18 years at the time of signing the informed consent form (). * Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. * Subject must have aggressive B-cell NHL according to 'the 2016 revision of the WHO classification of lymphoid neoplasms', histologically confirmed at last relapse by the treating institution, defined as: 1. Diffuse large B-cell lymphoma (DLBCL) Not otherwise specified (NOS) including transformed indolent Non-Hodgkin lymphoma (NHL) 2. Follicular lymphoma Grade 3B 3. T cell/histiocyte-rich large B-cell lymphoma 4. Epstein-Barr virus (EBV) positive DLBCL, NOS 5. Primary mediastinal (thymic) large B-cell lymphoma 6. High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma) * Subjects disease must have relapsed or be refractory to at least 2 prior lines of therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline. * Subject must have 1. Positron emission tomography (PET)-positive (Deauville score 4 or 5) and computed tomography (CT) measurable disease as per Lugano Classification 2. Sum of product of perpendicular diameters (SPD) of up to 6 index lesions >= 25 cm2 by CT scan (not applicable to Arm A or B or subjects with Richter's transformation) * Eastern Cooperative Oncology Group (ECOG) performance status <= 1 at screening * Adequate organ function * Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals * Participants must agree to use effective contraception Exclusion Criteria: * Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator´s judgment. * Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study based on investigator´s judgment. * Subject has any condition that confounds the ability to interpret data from the study based on investigator´s judgment. * Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for >= 2 years with the exception of the following non-invasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. 6. Other completely resected stage 1 solid tumor with low risk for recurrence * Prior treatment with any prior gene therap y product * Prior treatment with any adoptive T cell therapy; prior hematopoietic stem cell transplant (HSCT) is allowed * Allogeneic HSCT within 90 days of leukapheresis * Prior treatment with the combination agent from the assigned arm: 1. Anti PD-1 or PD-L1 (Arm A and E) 2. CC-122 (Arm B) 3. CC-220 (Arm C) 4. Prior treatment with ibrutinib is not exclusionary for subjects on any study arm 5. Anti LAG-3 targeted agent (Arm E) 6. CC-99282 (Arm F) * Presence of acute or chronic graft-versus-host disease (GVHD) * Presence of the following: 1. Active hepatitis B or active hepatitis C infection 2. History of or active human immunodeficiency virus (HIV) infection * Uncontrolled bacterial, viral or fungal infection at the time of leukapheresis, lymphodepleting chemotherapy or JCAR017 infusion * Any history of myocarditis (Arm E); history of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease (all arms) * History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis * Subjects with active CNS or cerebrospinal fluid (CSF) involvement by malignancy * Pregnant or nursing (lactating) women. * Subjects with active auto immune disorders/processes or active neurological or inflammatory disorders * For subjects to receive oral combination therapy (Arms B, C, D or F): History of a gastrointestinal (GI) condition or procedure that in the opinion of the investigator may affect oral drug absorption. * Progressive tumor invasion of venous or arterial vessels. * Deep venous thrombosis (DVT)/pulmonary embolism (PE) not managed on a stable regimen of anticoagulation. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04557436", "Brief_Title" : "TT52CAR19 Therapy for B-cell Acute Lymphoblastic Leukaemia (B-ALL)", "Official_title" : "Phase 1, Open Label Study of CRISPR-CAR Genome Edited T Cells (PBLTT52CAR19) in Relapsed /Refractory B Cell Acute Lymphoblastic Leukaemia", "Conditions" : ["B Acute Lymphoblastic Leukemia"], "Interventions" : ["Drug: PBLTT52CAR19"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary PBLTT52CAR19 modified T cells are allogenic engineered human T cells (defined as TT52CAR19 +TCRαβ-) prepared for the treatment of CD19+ B cell leukaemia. The cells are from healthy adult volunteer donors and are not HLA-matched. They have been transduced to express and anti-CD19 chimeric antigen receptor (CAR19) using a lentiviral vector that also incorporates CRISPR guides for genome editing of CD52 and TRAC loci in the presence of transiently provided Cas9. Recognition by TT52CAR19 T cells mediates eradication of CD19+ leukaemia and other CD19+ B cells through T cell mediated cytotoxicity. This study aims to apply PBLTT52CAR19 T cells to secure molecular remission in children with relapsed/refractory B-ALL ahead of programmed allogeneic stem cell transplantation. The cells are to be used in a time-limited manner for their anti-leukaemia effects and then depleted by standard pre- transplant conditioning. #Intervention - DRUG : PBLTT52CAR19 - gene therapy

#Eligibility Criteria: Inclusion Criteria: * Patients with relapsed (second or subsequent bone marrow relapse or bone marrow relapse after allo-SCT) or refractory (not achieving an initial complete response (CR) after 2 cycles of standard chemotherapy) CD19-positive B-acute lymphoblastic leukaemia * Morphologically confirmed with leukemic blasts in the bone marrow or a quantifiable MRD load of 1x10 <= age <= 4 (by multiparameter flow cytometry and/or quantitative polymerase chain reaction) * Eligible and fit for allogeneic hematopoietic stem cells transplantation with suitable donor available * Estimated life expectancy >= 12 weeks * Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age >= 16 years at the time of assent/consent) performance status >= 50 Eastern Cooperative Oncology Group ECOG performance status < 2 Exclusion Criteria: * Patients/parents unwilling to undergo a follow-up for 15 years * Foreseeable poor compliance to the study procedures * CD19-negative B-cell leukaemia * Evidence of disease progression after cytoreduction * Uncontrollable CNS leukaemia or neurological symptoms defined as CNS grade 3 (per National Comprehensive Cancer National guidelines). Patients developing grade 3 CNS disease at any time after enrolment will be excluded. * Absence of suitable HLA matched or mismatched donor * Weight < 6 kgs * Presence of donor-specific anti-HLA antibodies directed against PBLTT52CAR19 * GvHD requiring systemic therapy * Systemic steroid therapy prednisolone >0.5mg/kg/day * Known hypersensitivity to any of the test materials or related compounds * Active bacterial, fungal, or viral infection not controlled by a standard of care anti-microbial or anti-viral treatment. Uncontrolled bacteraemia/ fungaemia is defined as the ongoing detection of bacteria/fungus on blood cultures despite antibiotic or anti-fungal therapy. * Uncontrolled viraemia is defined as rising viral loads on two consecutive occasions despite antiviral therapy. * Risk of pregnancy or non-compliance with contraception (if applicable). Girls of childbearing potential must have been tested negative in a pregnancy test within 14 days prior to inclusion. * Lactating female participants unwilling to stop breastfeeding * Intrathecal methotrexate within 4 weeks or intrathecal chemotherapy (e.g Ara-C) within 2 weeks of lymphodepletion * Less than 2 half-lives from prior therapy with immune checkpoint pathway modifiers to lymphodepletion * Prior CAR19 therapy known to be associated with >=Grade 3 cytokine release syndrome (CRS) or >=Grade 3 drug-related CNS toxicity Sex : ALL Ages : - Minimum Age : 6 Months - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03585517", "Brief_Title" : "Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)", "Official_title" : "Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients", "Conditions" : ["AML"], "Interventions" : ["Drug: IM23"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML Detailed Description Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML and determine the best dosage. #Intervention - DRUG : IM23 - T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

#Eligibility Criteria: Inclusion Criteria: * Patients with CD123+ Refractory or Relapsed AML * To be aged 3 <= age <= 80 * Expression of CD123 in Blast >=90% * ECOG score <=2 * Voluntary participation in the clinical trials and sign the informed consent. Exclusion Criteria: * Intracranial hypertension or unconsciousness * Respiratory failure * CD19 negative * Disseminated intravascular coagulation * ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x -normal value * Hematosepsis or Uncontrolled active infection * Uncontrolled diabetes * Abalienation; * Patients in pregnancy or breast-feeding period * Previously treatment with any gene therapy products * Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04136275", "Brief_Title" : "CAR-37 T Cells In Hematologic Malignancies", "Official_title" : "A Phase I Clinical Trial With CAR-37 T Cells for the Treatment of Patients With Relapsed or Refractory CD37+ Hematologic Malignancies", "Conditions" : ["Hematologic Malignancy", "Leukemia", "Lymphoma", "Lymphoma, B-Cell", "Lymphoma, T-Cell", "Lymphoma, Non-Hodgkin"], "Interventions" : ["Biological: CAR-37 T cells"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This research study is studying Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) for treating people with relapsed or refractory CD37+ hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells. - Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) is an investigational treatment Detailed Description This is a two-part, non randomized, open label, single site Phase 1 study. Participants who fulfill eligibility criteria will be entered into the trial Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells). This study consists of 2 parts: * Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory CD37+ hematologic malignancies, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated * Part B (Expansion Cohort): Part B: Expansion Cohort: Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation). * A total of 18 participants will be enrolled to this trial This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. Investigational' means that the intervention is being studied The U.S. Food and Drug Administration (FDA) has not approved CAR-37 T Cells as a treatment for any disease. This is the first time that CAR-37 T Cells will be given to humans #Intervention - BIOLOGICAL : CAR-37 T cells - CAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells

#Eligibility Criteria: Inclusion Criteria: Voluntarily sign informed consent form. Age >=18 years of at the time of signing informed consent Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 Karnofsky >=60%, see Appendix A) * Diagnosis of relapsed/refractory (R/R) CD37+ hematologic malignancy as defined as one of the following: * Mature B cell neoplasms * Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a * RR disease after 2 or more prior lines of therapy AND * 1 of the prior lines of therapy must include an anti-CD20 antibody monotherapy. * Marginal Zone Lymphoma (MZL) nodal or extranodal: * R/R disease after 2 or more prior lines of therapy AND * 1 of the prior lines of therapy must include an anti-CD20 antibody monotherapy * Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and grade 3b Follicular Lymphoma (FL). * R/R disease after 2 or more prior lines of therapy OR * Relapsed following autologous SCT,OR * Ineligible for autologous SCT. * Mantle cell lymphoma * R/R disease as defined by disease progression after last regimen (including autologous SCT), OR Refractory disease as defined as failure to achieve a CR to last regimen. * Prior therapy must include: * Anthracycline or bendamustine-containing chemotherapy AND * Anti-CD20 monoclonal antibody therapy AND * BTKi therapy * Chronic lymphocytic leukemia (CLL) * CLL with an indication for treatment based on iwCLL guidelines and clinical measurable disease (lymphocytosis > 5×109/L and/or measurable lymph nodes and/or hepatic or splenomegaly) * Subjects must have received previous treatment as follows: * Subjects with high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), 17p deletion, TP53 mutation, or unmutated IGHV, must have failed at least 1 line of prior therapy, including a BTKi OR * Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR * Subjects who are BTKi intolerant and have received < 6 months of BTKi therapy, must have failed at least 1 high-risk line of non-BTKi therapy or 2 standard-risk lines of non-BTKi therapy OR * Subjects who are ineligible for BTKi, must have failed at least 1 (high-risk) line of non-BTKi therapy or 2 (standard-risk) lines of non-BTKi therapy. * Small lymphocytic lymphoma (SLL) * SLL (lymphadenopathy) or SLL (splenomegaly and < 5x 109 CD19+ CD5+ clonal B lymphocytes/L [<5000/μL] in the peripheral blood at diagnosis with measurable disease defined as at least one lesion > 1/5 cm in the greatest transverse diameter that is biopsy-proven SLL) * Subjects must have received previous treatments as follows: * Subjects with high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), or 17p deletion, or TP53 mutation, or unmutated IGHV, must have failed at least 1 line of prior therapy, including a BTKi OR * Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR * Subjects who are BTKi intolerant and have received < 6 months of BTKi therapy must have failed at least 1 high-risk or 2 standard-risk other lines of non-BTKi therapy OR * Subjects who are ineligible for BTKi, must have failed at least 1 high-risk or 2 standard-risk other lines of non-BTKi therapy. * Mature T cell neoplasms: * Peripheral T-Cell lymphoma (PTCL)/Cutaneous T-Cell Lymphoma (CTCL) * R/R after 2 or more prior lines of therapy OR * Relapse following autologous stem cell transplant OR * T-cell prolymphocytic leukemia (TPLL) --- Diagnosis of TPLL with plan for subsequent therapy. * Evidence of CD37 expression on tumor cells as demonstrated by flow cytometry and/or IHC on fresh biopsy or historic samples. * Subjects must have measurable disease according to appropriate disease specific criteria. * Adequate absolute lymphocyte count (ALC > 100 cells/ul) within one week of apheresis. * Adequate bone marrow function defined by absolute neutrophil count (ANC) >1000 cells/mm3 without growth factor support (filgrastim within 7 days of pegfilgrastim within 14 days) and untransfused platelet count >50,000 mm3. * Left ventricular ejection fraction > 40% * Adequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 × upper limit of normal (ULN) and direct bilirubin < 1.5 × ULN. * Adequate renal function defined by creatinine clearance >30 ml/min using the Cockcroft-Gault formula. * The effects of CAR-37 T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis and until 6 months post CAR-37 infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after last CAR-37 T cells administration. * Ability and willingness to adhere to the study visit schedule and all protocol requirements Inclusion criteria for lymphodepletion: * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 (Karnofsky >=60%, see Appendix A). * No Active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must be afebrile for 24 hours and blood cultures negative for 48 hours on appropriate antibiotic therapy. * Oxygen saturation >92% on room air while awake. * No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing. Exclusion Criteria: * Prior CD37 targeted therapies. * Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis. * Any systemic anti-cancer therapy within 1 weeks of leukapheresis excluding steroids at or below physiologic dosing. * Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed. * Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT. * Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury. * Active, uncontrolled, systemic bacterial, viral, or fungal infection. * Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy. * Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months. * Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation. * Subjects with history of a new pulmonary embolism within 6 months of beginning lymphodepletion. * Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy. * Pregnant or lactating women Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03980691", "Brief_Title" : "Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir", "Official_title" : "Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir", "Conditions" : ["HIV/AIDS"], "Interventions" : ["Biological: Chidamide with CAR-T or TCR-T cell therapy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To study the safety and effectiveness of the combination of Chidamide with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy on HIV patients based on cART. Detailed Description Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to cure human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which such reservoirs are eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells. Some studies have shown that Chidamide can highly activate the HIV reservoirs. The VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving suppressive cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. The purpose of this study is to evaluate the safety and efficacy of Chidamide together with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy based on cART in HIV-infected adults whose plasma HIV has been successfully suppressed after cART. #Intervention - BIOLOGICAL : Chidamide with CAR-T or TCR-T cell therapy - HIV-1 specific therapy

#Eligibility Criteria: Inclusion Criteria: * HIV infection confirmed * Receiving cART more than 12 months. * HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul. * Without serious liver , heart, liver and kidney diseases. * The subjects know about the study and volunteer to attend the research and sign the informed consent. Exclusion Criteria: * With active HBV or HCV infection, or serious opportunistic infections. * With serious chronic disease such like diabetes, the mental illness,et al * History of suffering from pancreatitis during cART . * Pregnant or breast-fed. * With poor adherence. * Unable to complete follow up. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03792633", "Brief_Title" : "Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL", "Official_title" : "Phase 2 Study of Humanized CD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19) for Very High-Risk Subsets of B Cell Acute Lymphoblastic Leukemia (B-ALL)", "Conditions" : ["Acute Lymphoid Leukemia"], "Interventions" : ["Biological: huCART19"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia. This study is targeting pediatric and young adult patients aged 1-29 years with CD19+ B cell malignancies in newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome with conventional chemotherapy, in high-risk first relapse, or and in second or greater relapse in this phase 2 trial. In addition, a second cohort will test the efficacy of huCART19 in patients with poor response to prior B cell directed engineered cell therapy. #Intervention - BIOLOGICAL : huCART19 - huCART19 infusion - Other Names : - huCTL019

#Eligibility Criteria: Inclusion Criteria: * Signed informed consent form must be obtained. * Relapsed or refractory B-cell ALL: a. Cohort A: Patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL who meet one of the following criteria: i. Newly diagnosed NCI HR B-ALL with induction failure: M3 marrow (>25% blasts) at end of induction OR ii. First marrow relapse of B-ALL at < 36 months from diagnosis OR iii. 2nd or greater relapse OR iv. Any relapse after allogeneic HSCT and >= 4 months from SCT at enrollment OR v. Refractory disease defined as having not achieved an MRD-negative and/or CSF-negative CR after >= 2 chemotherapy regimens/cycles of frontline therapy or 1 cycle of reinduction therapy for patients in first relapse OR vi. Ineligible for allogeneic SCT because of: * Comorbid disease * Other contraindications to allogeneic SCT conditioning regimen * Lack of suitable donor * Prior SCT * Declines allogeneic SCT as the therapeutic option after documented discussion, with expected outcomes, about the role of SCT with a BMT physician not part of the study team b. Cohort B: Patients previously treated with B cell directed engineered cell therapy who meet one of the following criteria: i. partial response or no response to prior cell therapy ii. CD19+ relapse after prior cell therapy iii. demonstrated early (<=6 months from infusion) B cell recovery suggesting loss of engineered cells c. Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion, must meet criteria in Section 5.3 of the protocol) * Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue by flow cytometry at relapse (or a recent sample in the case of refractory disease). If the patient has received CD19-directed therapy, then the flow cytometry should be obtained after this therapy to show CD19 expression. * Adequate organ function defined as: * A serum creatinine based on age/gender * ALT<= 500 U/L * Bilirubin <=2.0 mg/dl * Must have a minimum level of pulmonary reserve defined as <= Grade 1 dyspnea, < Grade 3 hypoxia; DLCO >= 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the treating investigator * Left Ventricular Shortening Fraction (LVSF) >= 28% or Ejection Fraction (LVEF) >= 45% confirmed by ECHO, or adequate ventricular function documented by a scan or a cardiologist. 5. Age 3 months to 29 years. 6. Adequate performance status (Lansky or Karnofsky score >=50). 7. Subjects of reproductive potential must agree to use acceptable birth control methods. Exclusion Criteria: 1. Active hepatitis B or active hepatitis C. 2. HIV Infection. 3. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy. 4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well. 5. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. 6. Pregnant or nursing (lactating) women. 7. Uncontrolled active infection. 8. Active medical disorder that, in the opinion of the investigator, would substantially increase the risk of uncontrollable CRS or neurotoxicity. Sex : ALL Ages : - Minimum Age : 3 Months - Maximum Age : 29 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02445248", "Brief_Title" : "Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients", "Official_title" : "A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)", "Conditions" : ["Diffuse Large B-cell Lymphoma (DLBCL)"], "Interventions" : ["Biological: Tisagenlecleucel", "Drug: Lymphodepleting chemotherapy"], "Location_Countries" : ["Italy", "Austria", "Australia", "Canada", "Netherlands", "Germany", "Norway", "France", "Japan", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL. Detailed Description This was a single arm, open-label, multi-center, Phase II study conducted to determine the efficacy and safety of tisagenlecleucel in adult patients with r/r DLBCL. The study consisted of the following sequential periods: Screening, Pre-Treatment, Treatment and Primary follow-up, Secondary follow-up, Survival follow-up. Patients were enrolled in 2 cohorts to receive one tisagenlecleucel infusion as follows: * Main Cohort (patients treated with tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US, referred to as 'US manufacturing facility') and * Cohort A (patients treated with tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany, referred to as 'EU manufacturing facility'). The study enrolled adult patients ≥ 18 years with histologically confirmed relapsed or refractory (r/r) DLBCL after ≥ 2 lines of chemotherapy, with a life expectancy of ≥ 12 weeks and not eligible or not consenting to stem cell transplantation (SCT). Patients had measurable disease at time of enrollment, adequate organ function and zero or one Eastern Cooperative Oncology Group performance status at screening. For each patient, the apheresis product of non-mobilized cells was received and accepted by the manufacturing site. #Intervention - BIOLOGICAL : Tisagenlecleucel - The target dose of CTL019 transduced cells for adult patients consisted of a single infusion of 5 x 10\^8 viable CTL019 transduced cells, which was administered via intravenous infusion. The acceptable dose range was 1 - 5x10\^8 viable CTL019 transduced cells. - Other Names : - CTL019 - DRUG : Lymphodepleting chemotherapy - Prior to CTL019 cell infusion, an additional lymphodepleting chemotherapy cycle was planned. The use of any additional bridging therapy prior to the recommended lymphodepleting chemotherapy was at the discretion of the investigator and dependent on the patient's disease burden. Lymphodepleting chemotherapy was started 14 to 5 days before CTL019 infusion (D1) to allow for at least 48 hours from last dose of lymphodepleting chemotherapy to CTL019 infusion. The lymphodepleting regimen was: Fludarabine (25 mg/m\^2 intravenously \[i.v.\] daily for 3 doses) and cyclophosphamide (250 mg/m\^2 i.v. daily for 3 doses starting with the first dose of fludarabine).

#Eligibility Criteria: Inclusion Criteria: * Written informed consent must be obtained prior to any screening procedures * Histologically confirmed DLBCL at last relapse(by central pathology review before enrolment. .- Relapsed or refractory disease after >=2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT * Measurable disease at time of enrollment * Life expectancy >=12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening * Adequate organ function: * Renal function defined as: * A serum creatinine of <=1.5 x Upper Limit of Normal ULN OR * Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73 m^2 * Liver function defined as: * Alanine Aminotransferase (ALT) <= 5 times the Upper Limit of Normal (ULN) for age * Bilirubin <= 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is <= 3.0 x ULN and direct bilirubin <= 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as <= Grade 1 dyspnea and pulse oxygenation > 91% on room air * Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) >= 45% confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA) * Adequate bone marrow reserve without transfusions defined as: * Absolute neutrophil count (ANC) > 1.000/mm^3 * Absolute lymphocyte count (ALC) >= 300/mm^3 and absolute number of CD3+ T cells > 150/mm^3 * Platelets >= 50.000//mm^3 * Hemoglobin > 8.0 g/dl * Must have an apheresis product of non-mobilized cells accepted for manufacturing * Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for at least 12 months following CTL019 infusion and until CAR T cells are no longer present by PCR on two consecutive tests Exclusion Criteria: * Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy * Treatment with any prior gene therapy product * Active Central Nervous System (CNS) involvement by malignancy * Prior allogeneic HSCT * Eligible for and consenting to HSCT * Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion * Investigational medicinal product within the last 30 days prior to screening * The following medications are excluded: * Steroids: Therapeutic doses of steroids must be stopped >72 hours prior to leukapheresis and >72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m^2/day hydrocortisone or equivalent * Immunosuppression: Any other immunosuppressive medication must be stopped >=2 weeks prior to leukapheresis and >= 2 weeks prior to CTL019 infusion. This could include check point inhibitors (monoclonal antibodies and small molecule modulators) * Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of leukapheresis and 2 weeks prior to infusion * Short acting drugs used to treat leukemia or lymphoma (e.g. tyrosine kinase inhibitors, and hydroxyurea) must be stopped > 72 hour prior to leukapheresis and > 72 hours prior to CTL019 infusion * Other cytotoxic drugs, including low dose daily or weekly maintenance chemotherapy, must not be given within 2 weeks prior to leukapheresis and within 2 weeks prior to CTL019 infusion * Fludarabine may be associated with prolonged lymphopenia. This should be taken into consideration when evaluating the optimal timing for leukapheresis collection. * Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respected antibody, whichever is longer * CNS disease prophylaxis must be stopped > 1 week prior to CTL019 infusion (e.g. intrathecal methotrexate) * Prior radiation therapy within 2 weeks of infusion * Active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive ) * HIV positive patients * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive <= 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 6 months prior to screening * Previous or concurrent malignancy with the following exceptions: * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry) * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study * A primary malignancy which has been completely resected and in complete remission for >= 5 years * Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 24 hours before lymphodepletion * Intolerance to the excipients of the CTL019 cell product * Cardiac arrhythmia not controlled with medical management * Prior treatment with any adoptive T cell therapy * Patients with T-cell rich/histiocyte rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV positive DLBCL of the elderly, Richter's transformation, and Burkitt lymphoma * Patients with active neurological auto immune or inflammatory disorders (e.g. Guillain Barre Syndrome, Amyptrophic Lateral Sclerosis) Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04853277", "Brief_Title" : "Patient Reported Outcomes and Patient Education in Cellular Therapy Patients", "Official_title" : "Effect of Patient Education Regarding Emotional Stressors on Patient Reported Outcomes in Patients Undergoing Cellular Therapy (HSCT or CAR-T)", "Conditions" : ["Stem Cell Transplant", "CAR T-Cell Transplant", "CAR T-Cell Therapy", "Cellular Therapy", "Hematopoietic Stem Cell Transplant", "HSCT", "Multiple Myeloma", "Leukemia", "Lymphoma"], "Interventions" : ["Behavioral: Education"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research is to provide an educational visit addressing common emotional stressors involved in the transplant/CAR-T process, and determine if this added education improves levels of anxiety, depression, and fatigue after transplant/CART in comparison to people who do not receive the brief educational visit. Detailed Description Individuals who decide to participate in this study, will be provided with a survey evaluating current symptoms. This survey should take approximately 10 minutes to complete. Individuals will then be scheduled for a 30 minute telephone visit to review common emotional stressors experienced after Stem Cell Transplant/CAR-T therapy as well as strategies to help reduce these symptoms. Participants will be provided with a pamphlet to review during the visit and independently afterwards. This visit will be conducted by telephone to avoid extra travel to the hospital, and will be conducted prior to admission for Transplant/CAR-T. Individuals will then be asked to fill out the same set of surveys at 1 month, 3 months, 6 months, and 12 months after receiving the transplant/CAR-T therapy. These surveys will be conducted during other scheduled clinic visits to avoid additional travel to the hospital. An individual's involvement will be complete at 1 year. If an individual receives post-transplant/CAR-T care at a hospital other than DHMC, surveys will be mailed to the participant to complete and return at the same time points. #Intervention - BEHAVIORAL : Education - Each Patient will undergo a 30 minute telephone visit with a trained Medical Provider outlining the timeline of various common emotional challenges experienced after transplant/CAR-T, as well as coping techniques. A pamphlet with information discussed will also be provided to the patient to review on their own time. The patient will have an opportunity to express any psychosocial/emotional concerns at this time.

#Eligibility Criteria: Inclusion Criteria: * Any patient with an underlying hematologic disease planning to undergo an autologous or allogeneic hematopoietic stem cell transplant (HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy at Dartmouth-Hitchcock Medical Center is eligible. * The patient must be approved for HSCT/CAR-T by the treating transplant physician. This includes completion of their pre-treatment work up and consent as directed by the standard DHMC SOPs. * Age >18 years, and no upper age limit Exclusion Criteria: * Any patient with medical, social, or psychological factors that would prevent the patient from cooperating with the trial and completing surveys at requested intervals. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02765243", "Brief_Title" : "Anti-GD2 4th Generation CART Cells Targeting Refractory and/or Recurrent Neuroblastoma", "Official_title" : "Anti-GD2 4th Generation Chimeric Antigen Receptor-modified T Cells (4SCAR-GD2) Targeting Refractory and/or Recurrent Neuroblastoma", "Conditions" : ["Neuroblastoma", "Effects of Immunotherapy"], "Interventions" : ["Biological: Anti-GD2 CART"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with refractory and/or recurrent neuroblastoma have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. The investigators are attempt to treat this disease using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (CAR) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill neuroblastoma through the recognition of GD2, a surface protein expressed at high levels on neuroblastoma but not on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent neuroblastoma. Detailed Description Background: Patients with refractory and/or recurrent neuroblastoma have poor prognosis despite complex multimodal therapy; therefore, novel curative approaches are needed. The investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a 4th generation GD2-specific chimeric antigen receptor (4SCAR-GD2). The chimeric antigen receptor (CAR) molecules enable the T cells to recognize and kill neuroblastoma through the recognition of a surface antigen, GD2, which is expressed at high levels in neuroblastoma but not at significant levels on normal tissues. This study will evaluate the side effects and the best dose of a novel 4th generation anti-GD2 CAR T cells to refractory and/or recurrent neuroblastoma. Objectives: 1. Primary: To determine the safety and feasibility of administration of 4SCAR-GD2 T cells to children with neuroblastoma following a cyclophosphamide/fludarabine preparative regimen. 2. Secondary: 1. To determine if the administration of 4SCAR-GD2 T cells can establish an antitumor effects in children with neuroblastoma who receive preparative regimen. 2. To describe the toxicity of administration of anti-GD2 CAR T cells in children with or without high-burden disease. 3. To evaluate the incidence and the treatment effect of cytokine release syndrome (CRS). 4. To determine the expansion and functional persistence of 4SCAR-GD2 T cells in the peripheral blood of patients and the correlation with antitumor effects. Eligibility: Patients 1-14 years of age, at least 10 kg, with neuroblastoma that has recurred after or not responded to standard therapy and is deemed incurable by standard therapy. Design: * Participants will be screened through physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow aspirates may be performed. * Peripheral blood mononuclear cells (PBMC) will be obtained by apheresis, and T cells will be activated and modified to express the 4SCAR-GD2 gene. * On Day -7, PBMC will be activated and enriched for T cells, which will be followed by 4SCAR-GD2 lentiviral transduction. The total culture time is approximately 5-10 days. * Participants will receive a preparative conditioning regimen comprising cyclophosphamide/fludarabine to prepare their immune system to accept the modified CAR T cells. The preparative regimen is consisted of fludarabine 25 mg/m(2) on days -4, -3 and -2 and cyclophosphamide 300 mg/m(2) on day-4, -3 and -2. * Participants will receive an infusion of the modified 4SCAR-GD2 T cells and closely followed up for treatment related responses. * Participants will have frequent follow-up visits to monitor the outcome of the treatment. #Intervention - BIOLOGICAL : Anti-GD2 CART - Anti-GD2 4th Generation Chimeric Antigen Receptor-modified T Cells

#Eligibility Criteria: INCLUSION CRITERIA: * Patients with neuroblastoma have received standard first-line therapy and been judged to be non-resectable, metastatic, progressive/persistent or recurrent. * The GD2 antigen status of the neuroblastoma will be determined for eligibility. Positive expression is defined by GD2 antibody staining results based on immunohistochemistry or flow cytometry analyses. * Body weight greater than or equal to 10 kg. * Age: >=1 year and <= 14 years at the time of enrollment. * Life expectancy: at least 8 weeks. * Prior Therapy: 1) There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less. 2) Must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3) At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic nonmyelosuppressive regimen. 4) At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5) At least 1 weeks since any radiation therapy at the time of study entry. * Karnofsky/jansky score of 60% or greater. * Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent . * Pulse Ox greater than or equal to 90% on room air. * Liver function: defined as alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN. * Renal function: Patients must have serum creatinine less than 3 times upper limit of normal. * Marrow function: White blood cell count >=1000/ul, Absolute neutrophil count >=500/ul, Absolute lymphocyte count >=500/ul, Platelet count >=25,000/ul (not achieved by transfusion). * Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable for hematologic toxicity. * Patients must have autologous transduced T cells at levels greater than or equal to 2x10e5 cells per kilogram body weight. * For all patients enrolled in this study, their parents or legal guardians must sign an informed consent and assent. EXCLUSION CRITERIA: * Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity. * Untreated central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible. * Previous treatment with other genetically engineered GD2-CAR T cells. * Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. * Patients who require systemic corticosteroid or other immunosuppressive therapy. * Patients previously experienced severe toxicity from cyclophosphamide or fludarabine. * Evidence of tumor potentially causing airway obstruction. * Inability to comply with protocol requirements. * Insufficient CAR T cells availability. Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 14 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05349201", "Brief_Title" : "CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)", "Official_title" : "CAR-T Cells - Real Life Study Of Care Pathway And Total Cost Of Care For Patients Under Car T-Cell Treatment Based On The PMSI French Database", "Conditions" : ["Diffuse Large B-Cell Lymphoma (DLBCL)", "Acute Lymphoblastic Leukemia (ALL)"], "Interventions" : ["Other: YESCARTA", "Other: KYMRIAH"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This was a Retrospective cohort study based on the PMSI data source Detailed Description A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (\~99% of French residents). The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified. The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay. CAR-T populations: KYMRIAH® DLBCL cohort: * Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. * Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019 YESCARTA®DLBCL cohort: * Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy: * Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019 KYMRIAH® ALL cohort: * Pediatric and young adult patients (≤ 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse: * Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019 #Intervention - OTHER : KYMRIAH - Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse - OTHER : YESCARTA - Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])

#Eligibility Criteria: Inclusion Criteria: * Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And * Patients diagnosed with ALL or DLBCL when administering CAR-T cells and * up to 25 years for patients with ALL Exclusion Criteria: * All patients treated outside the two types of indications presented in the inclusion criteria will be excluded Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04812691", "Brief_Title" : "CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma", "Official_title" : "CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma, Phase Ⅰ,Open-label,Single-arm,Muticenter Study", "Conditions" : ["Diffuse Large B Cell Lymphoma"], "Interventions" : ["Biological: JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China Detailed Description This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment. One dose level of 1.0 x 10\^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion. #Intervention - BIOLOGICAL : JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) - Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10\^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.

#Eligibility Criteria: Inclusion Criteria: * >= 18 years; * Sign on the informed consent; * Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy; * Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Adequate organ function; * Adequate vascular access for leukapheresis procedure; * Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; * Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; * Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029 Exclusion Criteria: * Subjects who have received second-line treatment or above * CD19 negative * Primary CNS lymphoma; * History of another primary malignancy that has not been in remission for at least 2 years; * Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; * Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; * Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * Presence of acute or chronic graft-versus-host disease (GVHD); * History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; * Pregnant or nursing women; * Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * Received CAR T-cell or other genetically-modified T-cell therapy previously. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04840875", "Brief_Title" : "Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma", "Official_title" : "Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma", "Conditions" : ["T Cell Lymphoma", "T-cell Leukemia"], "Interventions" : ["Biological: chimeric antigen receptor T cell treatment"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion. #Intervention - BIOLOGICAL : chimeric antigen receptor T cell treatment - Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.

#Eligibility Criteria: Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7 * Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks * Male or female, aged 0 <= age <= 70 years * No serious allergic constitution * Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2 * Have life expectancy of at least 60 days based on investigator's judgement * CD7 positive in bone marrow or peripheral blood or immunohistochemistry * Candidates aged 8 <= age <= 70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years could be recruited after signing an informed consent form by a legal surrogate (Guardian) * Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Intracranial hypertension or disorder of consciousness * Symptomatic heart failure or severe arrhythmia * Symptoms of severe respiratory failure * Complicated with other types of malignant tumors * Diffuse intravascular coagulation * Serum creatinine and / or blood urea nitrogen >= 1.5 times of the normal value * Suffering from septicemia or other uncontrollable infections * Patients with uncontrollable diabetes * Severe mental disorders * Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI) * Have received organ transplantation (excluding hematopoietic stem cell transplantation); * Reproductive-aged female patients with positive blood HCG test * Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis Sex : ALL Ages : - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03338972", "Brief_Title" : "Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma", "Official_title" : "A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen (BCMA)+ Multiple Myeloma With Autologous CD4+ and CD8+ T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor", "Conditions" : ["Recurrent Plasma Cell Myeloma", "Refractory Plasma Cell Myeloma"], "Interventions" : ["Drug: Fludarabine", "Drug: Cyclophosphamide", "Biological: Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143", "Procedure: Leukapheresis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count in the blood, which may help the infused BCMA CAR-T cells survive and expand. Detailed Description PRIMARY OBJECTIVE: I. To evaluate the safety of adoptive therapy with ex vivo expanded autologous CD8+ plus CD4+ T cells transduced to express a human B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) for patients with relapsed or treatment refractory multiple myeloma. SECONDARY OBJECTIVES: I. To determine the duration of in vivo persistence and the phenotype of long lived CAR-T cells. II. To determine the degree to which adoptively transferred T cells traffic to multiple myeloma (MM) cells in the bone marrow (BM) and function in vivo. III. To estimate the antitumor activity of adoptively transferred BCMA-specific CAR-expressing T lymphocytes (BCMA CAR-T cells). OUTLINE: This is a dose-escalation study of BCMA-specific CAR-expressing T lymphocytes. Patients undergo leukapheresis to obtain their immune cells, from which CAR-T cells are produced. A few weeks later, patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning 36-96 hours after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes intravenously (IV) over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). After completion of study treatment, patients are followed up at 60, 90, 120, 180, and 365 days and then annually up to 15 years. #Intervention - BIOLOGICAL : Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 - Given IV - Other Names : - Autologous Anti-BCMA-CAR CD4+/CD8+ Cells, Autologous Anti-BCMA-CAR-expressing CD8+ and CD4+ T-lymphocytes, BCMA CAR-CD4+/CD8+ T-cells, BCMA-specific CAR-expressing CD4+/CD8+ T-lymphocytes, FCARH143 - DRUG : Cyclophosphamide - Given IV - Other Names : - (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719 - DRUG : Fludarabine - Given IV - Other Names : - Fluradosa - PROCEDURE : Leukapheresis - Undergo leukapheresis - Other Names : - Leukocytopheresis, Therapeutic Leukopheresis

#Eligibility Criteria: Inclusion Criteria: * Have the capacity to give informed consent * Eastern Cooperative Oncology Group (ECOG) performance status score =< 2. * Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings: * Serum M-protein >= 1 g/dL * Urine M-protein >= 200 mg/24 hour * Involved serum free light chain (sFLC) level >= 10 mg/dL with abnormal kappa/lambda ratio * Measurable biopsy-proven plasmacytomas (>= 1 lesion that has a single diameter >= 2 cm) * Bone marrow plasma cells >= 30% * Have a diagnosis of BCMA+ MM (>= 5% BCMA+ by flow cytometry on CD138 co-expressing plasma cells obtained within 45 days of study enrollment); the MM diagnosis must be confirmed by internal pathology review of a fresh biopsy specimen at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA) * Have relapsed or treatment refractory disease with >= 10% CD138+ malignant plasma cells (IHC) on BM core biopsy, either: * Following autologous stem cell transplant (ASCT) * Or, if a patient has not yet undergone ASCT, the individual must: * Be transplant ineligible, due to age, comorbidity, patient choice, insurance reasons, concerns of rapidly progressive disease, and/or discretion of attending physician and principal investigator and, * Demonstrate disease that persists after > 4 cycles of induction therapy and that is double refractory (persistence/progression) after therapy with both a proteasome inhibitor and immunomodulatory drug (IMiD) administered either in tandem, or in sequence; > 4 cycles of therapy are not required for patients with a diagnosis of plasma cell leukemia * Patients receiving retreatment do not need to meet the > 10% CD138+ malignant plasma cells (immunohistochemistry staining method [IHC]) on BM core biopsy * Male and female patients of reproductive potential must be willing to use an effect contraceptive method before, during, and for at least 4 months after the CAR T cell infusion Exclusion Criteria: * History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year (the following are exempt from the 1 year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear) * Active hepatitis B, hepatitis C at the time of screening * Patients who are (human immunodeficiency virus [HIV]) seropositive * Subjects with uncontrolled active infection * > 1 hospital admission (lasting 5 days or more) for documented infection in prior 6 months * Presence of acute or chronic graft-versus-host disease (GVHD) requiring active treatment unless limited to skin involvement and managed with topical steroid therapy alone * History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease as determined by the principal investigator (PI) or designee * History of clinically relevant or active central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis, active central nervous system MM involvement and/or carcinomatous meningitis; subjects with previously treated central nervous systems involvement may participate, provided they are free of disease in the CNS (documented by flow cytometry performed on the cerebrospinal fluid [CSF] within 14 days of enrollment) and have no evidence of new sites of CNS activity * Pregnant or breastfeeding females * Allogeneic HSCT or donor lymphocyte infusion within 90 days of leukapheresis. * Use of any of the following: * Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted * Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis * Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis * Daratumumab (or other anti-CD38 therapy) within 30 days of leukapheresis * Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis * Absolute neutrophil count (ANC) < 1000/mm^3, or per PI discretion if cytopenia thought to be related to underlying myeloma. * Hemoglobin (Hgb) < 8 mg/dl, or per PI discretion if cytopenia thought to be related to underlying myeloma. * Platelet count < 50,000/mm^3, or per PI discretion if cytopenia thought to be related to underlying myeloma. * Active autoimmune disease requiring immunosuppressive therapy * Major organ dysfunction defined as: * Creatinine clearance < 20 ml/min * Significant hepatic dysfunction (serum glutamic-oxaloacetic transaminase [SGOT] > 5 x upper limit of normal; bilirubin > 3.0 mg/dL) * Forced expiratory volume in 1 second (FEV1) of < 50% predicted or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% (patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing) * Anticipated survival of < 3 months * Contraindication to cyclophosphamide or fludarabine chemotherapy * Patients with known AL subtype amyloidosis * Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the PI; or unwillingness or inability to follow the procedures required in the protocol Sex : ALL Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03744676", "Brief_Title" : "A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)", "Official_title" : "A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting", "Conditions" : ["Lymphoma, Non-Hodgkin", "Lymphoma", "Lymphoma, B-Cell", "Lymphoma, Large B-Cell, Diffuse", "Neoplasms", "Neoplasms by Histologic Type", "Lymphoproliferative Disorders", "Lymphatic Diseases", "Immunoproliferative Disorders", "Immune System Disorder"], "Interventions" : ["Biological: lisocabtagene maraleucel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years. Detailed Description This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting. Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration. #Intervention - BIOLOGICAL : lisocabtagene maraleucel - lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection - Other Names : - JCAR017, liso-cel

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years at the time of consent * Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT. * Positron-emission tomography-positive disease by Lugano Classification * Eastern Cooperative Oncology Group performance status of 0 to 1 * Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function * Adequate vascular access for leukapheresis procedure * Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy * Subjects must agree to use appropriate contraception. Exclusion Criteria: * Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study) * History of prior allogeneic hematopoietic stem cell transplant * Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis * History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear. * Active hepatitis B or hepatitis C infection at the time of screening * History of or active human immunodeficiency virus infection at the time of screening * Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration * Presence of acute or chronic graft-versus-host disease * History of clinically significant cardiac conditions within the past 6 months * History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis * Pregnant or nursing women * Subject does not meet protocol-specified washout periods for certain prior treatments * Prior CAR T-cell or other genetically modified T-cell therapy * Progressive vascular tumor invasion, thrombosis, or embolism * Venous thrombosis or embolism not managed on stable regimen of anticoagulation * Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01837602", "Brief_Title" : "cMet CAR RNA T Cells Targeting Breast Cancer", "Official_title" : "Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer", "Conditions" : ["Metastatic Breast Cancer", "Triple Negative Breast Cancer"], "Interventions" : ["Biological: cMet RNA CAR T cells"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary An open-label, clinical trial of autologous cMet redirected T cells administered intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with operable triple negative breast cancer. Detailed Description This study is designed to determine the safety and feasibility of intratumoral administration of autologous T cells that have had genetic material transferred into the cell to redirect them to target breast cancer cells rather than their usual target. Eligible subjects will have metastatic breast cancer refractory to at least one standard therapy or to newly diagnosed with operable triple negative breast cancer. #Intervention - BIOLOGICAL : cMet RNA CAR T cells

#Eligibility Criteria: Inclusion Criteria: * Step 1 subjects only: metastatic breast cancer patients with an accessible tumor (cutaneous, subcutaneous, or superficial) and/or palpable adenopathy/mass. The targeted tumor is accessible (i.e. is not near a great vessel or the spinal cord) and can be surgically excised or biopsied. * Step 2 subjects only: Newly diagnosed, operable, triple negative breast cancer, i.e. ER/PR-negative, her2/neu-negative, with tumor size between 2 - 3 cm (T2) as measured by either clinical breast exam, mammogram, ultrasound or MRI, with or without ipsilateral axilla node involvement (N0 or N1). * cMet expression in >= 30% tumor cells as demonstrated on immuno-histochemistry analysis of archival slides. The intensity for cMet IHC should be greater than or equal to 1+. Punch biopsy or percutaneous core biopsy may be offered to Cohort 1 patients. To establish eligibility for patients in step 1, archival tumor tissues from any previously biopsied metastatic tumor deposit may be used for IHC staining. The metastatic tumor nodule to be targeted for IT injection may not necessarily be the same as previously biopsied metastatic site. * Age > 18 years * Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1 * Adequate hematologic function: WBC > 3.0 Plt > 75,000 Hgb > 10 g/dl Adequate renal function defined as serum creatinine < 1.5 times upper limit of normal * Adequate hepatic function defined as: Total bilirubin < 1.5 times upper limit of normal, and ALT and AST < 2.5 times upper limit of normal * Women of child bearing potential must have a negative pregnancy test (blood or urine) and agree to use appropriate contraception from study screen through the duration of the trial. Men must agree to use appropriate contraception from IT injection through the duration of the trial. * Signed and dated written informed consent. Exclusion Criteria: * Step 1 subjects only: Targeted tumor near a great vessel or spinal cord * Step 2 subjects only: Women already undergoing neoadjuvant chemotherapy to treat their primary triple negative breast cancer * Step 1 and 2 subjects:Positive for HIV-1/HIV-2 * Active hepatitis B or hepatitis C infection * The anticipated use of the following within 2 weeks prior to apheresis and prior to planned IT T-cell injection: Immunosuppressive drugs Cytotoxic chemotherapy (See Section 5.7 for complete details) Systemic glucocorticoids (steroid prep due to dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy is allowed) Hematopoietic growth factors Other experimental therapy Note: Step 1 patients receiving non-investigational targeted therapy (lapatinib, trastuzumab, and/or pertuzumab) are eligible provided these medicines are at a stable dose and the patient began taking them more than 30 days prior to the planned IT T-cell injection. * Anticipated use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before the planned IT T-cell injection RETIRED AS OF PROTOCOL VERSION 11 * Pregnant women or nursing mothers * History of alcohol abuse or illicit drug use within 12 months of IT T-cell injection * Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results * Significant psychiatric disorder and any other reason that in the Investigator's opinion would jeopardize protocol compliance or compromise the patient's ability to give informed consent. * Prior MI ascertained from medical history and review of systems Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01475058", "Brief_Title" : "CD19 CAR T Cells for B Cell Malignancies After Allogeneic Transplant", "Official_title" : "A Phase I/II Study of Cellular Immunotherapy With Donor Central Memory-derived Virus-specific CD8+ T-cells Engineered to Target CD19 for CD19+ Malignancies After Allogeneic Hematopoietic Stem Cell Transplant", "Conditions" : ["Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia", "Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia", "Recurrent Adult Acute Lymphoblastic Leukemia", "Recurrent Adult Diffuse Large Cell Lymphoma", "Recurrent Adult Immunoblastic Large Cell Lymphoma", "Recurrent Mantle Cell Lymphoma", "Refractory Chronic Lymphocytic Leukemia"], "Interventions" : ["Biological: allogeneic cytomegalovirus-specific cytotoxic T lymphocytes"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy. Detailed Description PRIMARY OBJECTIVES: I. To assess the safety and feasibility of pre-emptive adoptive T cell therapy using ex vivo expanded cytomegalovirus (CMV)- or Epstein-Barr virus (EBV)-specific T cells derived from donor CD62L+ central memory (TCM) cells and genetically modified to express a CD19-specific chimeric antigen receptor (CAR) in patients in complete remission after human leukocyte antigen (HLA)-matched related donor hematopoietic stem cell transplantation (HCT) for CD19+ B cell malignancies at high risk of post-HCT relapse. (Cohort A) II. To assess the safety and feasibility of adoptive T cell therapy using ex vivo expanded CMV- or EBV-specific T cells derived from donor CD62L+ TCM cells and genetically modified to express a CD19-specific CAR in patients with persistent, progressive or relapsed disease after HLA-matched related donor HCT for CD19+ B cell malignancies. (Cohort B) SECONDARY OBJECTIVES: I. To determine the duration of in vivo persistence of adoptively transferred bi-specific CD8+ T cells, and the phenotype of persisting T cells. II. To determine if adoptively transferred bi-specific CD8+ T cells traffic to the bone marrow and function in vivo. III. To determine if adoptively transferred bi-specific CD8+ T cells proliferate in allogeneic HCT recipients that reactivate CMV or EBV. IV. To determine if the adoptive transfer of bi-specific CD8+ T cells eliminates CD19+ tumor cells in the subset of patients with a measurable tumor burden prior to T cell transfer. OUTLINE: At least 30 days after HCT, patients will receive one intravenous (IV) infusion of CMV/CD19 or EBV/CD19 bi-specific CD8+ T cells. After completion of study treatment, patients are followed up periodically for 15 years. #Intervention - BIOLOGICAL : allogeneic cytomegalovirus-specific cytotoxic T lymphocytes - Allogeneic CD19-specific chimeric antigen receptor-modified CD8+ central memory derived virus-specific T cells. Allogeneic CD19CAR-TCM cells given IV - Other Names : - allogeneic CMV-specific CTLs

#Eligibility Criteria: Inclusion Criteria: * Patients with CD19+ B cell malignancy who have persistent, relapsed or progressive disease after hematopoietic stem cell transplant from an human leukocyte antigen (HLA)-matched related donor OR patients with CD19+ B cell malignancy who are planned for or have had a hematopoietic stem cell transplant from an HLA-matched related donor and are at risk of relapse after HCT defined by any one of the disease-specific criteria listed below: * Philadelphia chromosome negative acute lymphoblastic leukemia: * Beyond first complete remission (CR) at the time of pre-transplant evaluation * Required > 1 cycle of induction chemotherapy to achieve CR * First morphologic CR but with evidence of minimal residual disease by flow cytometry, conventional cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR) * First CR with poor risk cytogenetics (t(4:11), t(8;14), hypodiploidy, near triploidy or > 5 cytogenetic abnormalities) at diagnosis * Planned for or have had a reduced intensity conditioned or non-myeloablative transplant * Philadelphia positive acute lymphoblastic leukemia * Not in CR at the time of pre-transplant evaluation * In CR with the following features: * Intolerant or unwilling to use a TKI after HCT * Current or previous detection of cytogenetic abnormalities in addition to t(9;22) by conventional karyotyping, FISH or molecular methods * Chronic lymphocytic leukemia, or low grade B cell lymphomas: * Failed or ineligible for prior immunochemotherapy that included a purine analog and anti-CD20 monoclonal antibody AND a lymph node >= 5 cm at the time of pre-transplant evaluation * Mantle cell lymphoma: * Failed or ineligible for autologous transplant AND a lymph node >= 2 cm at the time of pre-transplant evaluation * Diffuse large B cell lymphomas, large B cell transformation of an indolent lymphoma or other aggressive B cell lymphomas * Failed or ineligible for autologous transplant AND not in CR at the time of pre-transplant evaluation * Confirmation of tumor diagnosis and expression of CD19 after review by University of Washington Medical Center (UWMC) or Seattle Cancer Care Alliance (SCCA) pathology services * The patient has signed the informed consent form for this study * DONOR: Genotypic or phenotypic HLA-identical family members * DONOR: Express one or more of the following combinations of viral serostatus and HLA allele: * CMV seropositive and HLA-A*0101 positive * CMV seropositive and HLA-A*0201 positive * CMV seropositive and HLA-B*0702 positive * CMV seropositive and HLA-B*0801 positive * EBV seropositive and HLA-A*0201 positive * EBV seropositive and HLA-B*0801 positive * DONOR: Hematocrit >= 35% at enrollment * DONOR: Age >= 18 years * DONOR: The donor has signed the informed consent form for the study Exclusion Criteria: * Known central nervous system (CNS) tumor (CNS2 or CNS3) that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation; patients with a history of CNS disease that has been effectively treated to CNS1 or lower evidence of disease will be eligible * Human immunodeficiency virus (HIV) seropositive * Significant medical or psychological conditions that would make them unsuitable candidates for T cell therapy * Fertile patients unwilling to use contraception during and for 12 months after protocol enrollment * Pregnant or breast-feeding * DONOR: G-CSF administered within one month prior to the blood draw for T cell collection * DONOR: Unable for any reason to provide a 400 ml blood draw * DONOR: Inadequate peripheral veins for blood collection * DONOR: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1 or HTLV-2 seropositive * DONOR: Active hepatitis B or hepatitis C virus infection * DONOR: Positive serologic test for syphilis * DONOR: Aberrant CD45RA isoform expression on all T cells * DONOR: Systolic blood pressure (BP) < 80 or > 200 * DONOR: Heart rate < 50 or > 120, if considered due to cardiac disease * DONOR: Oxygen (O2) saturation < 88% on room air * DONOR: Serum creatinine (Cr) > 3.0 * DONOR: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 4 x the upper limit of normal * DONOR: Unable to provide informed consent to participate * DONOR: Significant medical conditions (e.g. immunosuppressive therapy) that would make them unsuitable T cell donors * DONOR: Pregnant or nursing Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03173417", "Brief_Title" : "Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)", "Official_title" : "Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients", "Conditions" : ["Leukemia"], "Interventions" : ["Drug: fludarabine and cyclophosphamide", "Biological: IM19 CAR-T"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia. Detailed Description Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best dosage. #Intervention - BIOLOGICAL : IM19 CAR-T - T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor - Other Names : - IM19 - DRUG : fludarabine and cyclophosphamide - Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days - Other Names : - FC

#Eligibility Criteria: Inclusion Criteria: * Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens） * To be aged 3 <= age <= 75 * Blast in blood <= 30% * ECOG score <=2 * Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time. * Voluntary participation in the clinical trials and sign the informed consent. Exclusion Criteria: * Intracranial hypertension or unconsciousness * Respiratory failure * CD19 negative * Disseminated intravascular coagulation * ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x normal value * Hematosepsis or Uncontrolled active infection * Uncontrolled diabetes * Abalienation; * WHO Sscore >3 * Patients in pregnancy or breast-feeding period * Previously treatment with any gene therapy products * Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial * Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation. Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01897415", "Brief_Title" : "Autologous Redirected RNA Meso CAR T Cells for Pancreatic Cancer", "Official_title" : "Phase I Clinical Trial of Autologous Mesothelin Re-directed T Cells in Patients With Chemotherapy Refractory Metastatic Pancreatic Cancer", "Conditions" : ["Subjects With Metastatic Pancreatic Ductal Adenocarcinoma (PDA)"], "Interventions" : ["Biological: Autologous T cells transfected with chimeric anti-mesothelin immunoreceptor SS1"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase I safety and feasibility study. Subjects will be enrolled serially. For subject safety, the preceding subject must have completed one cycle of therapy (28 days) before the next subject can be treated. Subjects will be treated with i.v. administration of 1 to 3e8 per meter squared RNA CAR T cells three times weekly (M-W-F) for three weeks. Detailed Description This phase I study is being conducted to establish safety and feasibility of intravenous (IV) RNA mesothelin re-directed autologous T cell administration in patients with chemotherapy-refractory metastatic pancreatic cancer. Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and be 28 days from their last infusion before the next subject can be treated.. Subjects will be treated with IV administration of 1 to 3e8/m2 RNA CAR T cells three times weekly (M-W-F) for three weeks. Main eligibility criteria: Subjects with metastatic pancreatic ductal adenocarcinoma (PDA) who have chemotherapy-refractory disease. Inclusion criteria include patients older than 18 years of age diagnosed with metastatic PDA with ECOG 0-1 performance status and 3 month expected survival. Exclusion criteria include a pericardial effusion, active autoimmune disease requiring immunosuppressive therapy, active anti-coagulation therapy, known HIV or HTLV I/II positivity, prior treatment with murine monoclonal antibodies or history of allergy to murine proteins. #Intervention - BIOLOGICAL : Autologous T cells transfected with chimeric anti-mesothelin immunoreceptor SS1

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed metastatic pancreatic adenocarcinoma. * Patients greater than or equal to 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy greater than 3 months. * Evidence of metastatic disease and failure of at least 1 prior chemotherapy for metastatic disease. * Subjects must have measureable disease as defined by RECIST 1.1 criteria. * Satisfactory organ and bone marrow function * Blood coagulation parameters: PT such that international normalized ratio (INR) is less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than or equal to 1.2 time the upper limit of normal. * Subjects must have adequate venous peripheral access for apheresis. Patients must also have adequate venous access for subsequent modified CAR T cell administration which can be done through a central venous access (e.g. port for systemic chemotherapy) * Ability to understand and the willingness to provide written informed consent. * Short-term therapy for acute conditions not specifically related to pancreatic cancer is allowed if such therapy does not include immune modulating agents. * Male and Female subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 3 months following the last dose of the study cell infusion. * Subject must understand and sign the study-specific informed consent. Exclusion Criteria: * Participated in any other trial in which receipt of an investigational study drug occurred within 28 days (42 days for non-murine monoclonal antibodies) prior to entry into the study. * Received any anticancer medication in the 2 weeks (i.e. 14 days) prior to receiving their first dose of study treatment and no other concurrent chemotherapy or immunotherapy (e.g. monoclonal antibodies) * Active invasive cancer other than pancreatic adenocarcinoma. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder and prostate cancer with PSA level less than 1.0) are not excluded. * Known HIV, HCV, and HBV positive * Active autoimmune disease (including but not limited to: systemic lupus erythromatosis, Sjogrens syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within the past 4 weeks, with exception of thyroid replacement. * Patients with ongoing or active infection. * Planned concurrent treatment with systemic high dose corticosteroids. * Prior gene therapy or therapy with murine monoclonal antibodies or products of murine origin. * Concurrent treatment with any anticancer agent. * History of allergy to murine proteins * History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) * Any clinically significant pericardial effusion; CHF (NY Heart Association Grade II-IV) or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis. * Subjects on active anti-coagulation therapy. * Pregnant women are excluded from this study because autologous transduced T cells may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, secondary to treatment of the mother with autologous transduced T cells, breastfeeding should be discontinued if the mother is treated. * Feasibility assessment demonstrates less than 20% transfection of target lymphocytes or insufficient expansion of modified CAR T cells to complete 9 infusions. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04650724", "Brief_Title" : "Clinical Study of T Cell Infusion Targeting BCMA Chimeric Antigen Receptor", "Official_title" : "Single Arm, Single Center, Open Label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA Positive Recurrent or Refractory Multiple Myeloma", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: T cell infusion agent targeting BCMA chimeric antigen receptor"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells. BCMA is a specific surface protein of B lymphocytes, which plays an important role in the development, proliferation and differentiation of B cells. BCMA is highly expressed in malignant mm plasma cells and provides a large number of anti apoptotic signals, which makes bcam an ideal target in targeted immunotherapy. At present, a variety of immunotherapy strategies targeting BCMA are being carried out in laboratory and clinical practice, which have achieved encouraging therapeutic effects in multiple myeloma and effectively promoted the development of targeted immunotherapy. #Intervention - DRUG : T cell infusion agent targeting BCMA chimeric antigen receptor - Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

#Eligibility Criteria: Inclusion Criteria: * 1. Subjects who voluntarily participated in the study and signed written informed consent; 2. The age of signing informed consent is 14 <= age <= 65 years; 3. Patients with multiple myeloma were diagnosed according to the IMWG diagnostic criteria; 4. The expression of BCMA was confirmed by flow cytometry or immunohistochemistry; 5. The expected survival time was > 12 weeks; 6. The main researchers and attending physicians believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation; 7. Relapsed or refractory multiple myeloma (mm) A. At least one complete regimen including induction, consolidation and maintenance of proteasome inhibitors and / or immunomodulators was performed at least once, and the interval between the two regimens was more than 3 months; B. According to the criteria of IMWG, recurrence was considered; C. Refractory patients (disease progression during standard treatment; efficacy of proteasome inhibitor combined with immunomodulator less than PR; efficacy after autologous stem cell transplantation less than PR; disease progression within 6 months after transplantation; progression and recurrence within 1 year after initial treatment); D. Recurrence occurred after allogeneic SCT treatment; 8. The main organ functions are sound, including: A. Renal function: serum creatinine clearance rate > 40 ml / min / 1.73 m2, adjusted according to age / gender standard; B. Alanine transferase (ALT) was less than 2 times the normal maximum value of the same age; C. Bilirubin < 2.0 mg / dl; D. Echocardiography or multi gated angiography (MUGA) showed left ventricular short axis shortening (LVSF) >= 28%, or left ventricular ejection fraction (LVEF) >= 45%; 9. ECOG physical status (PS) <= 2; 10. The pregnant test results of fertile female subjects within 48 hours before infusion were negative, and they were not in lactation period; all subjects with reproductive potential should take adequate contraceptive measures from the beginning of the study to one year after the end of the study. Exclusion Criteria: * 1. Pregnant or lactating female patients; 2. Participate in another clinical trial within 4 weeks before enrollment (3 months in case of monoclonal antibody clinical trial) or intend to participate in another clinical trial during the whole study period; 3. Other anti BCMA treatments have been used in the past; 4. Uncontrolled active infection; for example, there is a known history of human immunodeficiency virus; active hepatitis B or hepatitis C infection; HBV-DNA detection exceeds normal, etc; 5. There is grade 2 <= age <= 4 acute or systemic chronic GVHD or GVHD under treatment; 6. Cns-3 disease progression, or the presence of central nervous system parenchymal lesions that may increase the central nervous system toxicity; patients with active central nervous system leukemia infiltration; 7. The researchers think that they are not suitable to participate in this clinical trial due to various reasons. Sex : ALL Ages : - Minimum Age : 14 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05907603", "Brief_Title" : "Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)", "Official_title" : "Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies", "Conditions" : ["Neoplasms", "Hematologic Neoplasms", "Hematologic Diseases"], "Interventions" : ["Drug: RD13-02 cell infusion"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients. #Intervention - DRUG : RD13-02 cell infusion - CAR-T cells

#Eligibility Criteria: Inclusion Criteria: * Age 3 <= age <= 70 * Diagnosis of r/r T-ALL/LBL/AML. * CD7 positive expression * Bone marrow lymphoblasts >=5% by morphologic evaluation at screening * Creatinine clearance (as estimated by Cockcroft Gault) >= 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or <=1.5mg/dl * Left ventricular ejection fraction >= 50% . * Baseline oxygen saturation >= 92% on room air. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * The estimated survival time is more than 3 months. * Subjects or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: * For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC). * Subjects with concomitant genetic syndromes associated with bone marrow failure states. * Subjects with some cardiac conditions will be excluded. * History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. * History of malignancy other than non-melanoma skin cancer or carcinoma. * Primary immune deficiency. * Presence of uncontrolled infections. * Subjects with some anticancer therapy before CAR-T infusion will be excluded. * Active uncontrolled acute infections. * Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis. * Subjects who are receiving systemic steroid therapy prior to screening. * Subjects with acute graft-versus-host disease (GvHD) * Having received live/attenuated vaccine within 4 weeks prior to screening. * History of allergy to any component of the cell therapy product. * Pregnant or breastfeeding women * Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study. Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT06392763", "Brief_Title" : "Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data", "Official_title" : "Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data", "Conditions" : ["Diffuse Large B-cell Lymphoma", "Acute Lymphoblastic Leukemia (ALL)"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.

#Eligibility Criteria: Inclusion criteria: DLBCL population: * Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND * Diagnosed with DLBCL (International Classification of Diseases [ICD-10 C833]) when receiving CAR-T AND * Being 18 years or older. ALL population: * Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND * Diagnosed with ALL (ICD-10 C910) when receiving CAR-T AND * Being 25 years or younger. Exclusion criteria: DLBCL population: * Patients hospitalised with a diagnosis other than DLBCL during the historical period or during the index stay. ALL population: * Patients hospitalised with a diagnosis other than ALL during the historical period or during the index stay. Sex : ALL Ages : - Minimum Age : 1 Year - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04316624", "Brief_Title" : "A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy", "Official_title" : "A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy", "Conditions" : ["Diffuse Large B Cell Lymphoma"], "Interventions" : ["Drug: C-CAR066"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy. Detailed Description This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection. The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit. #Intervention - DRUG : C-CAR066 - Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously

#Eligibility Criteria: Inclusion Criteria: * The patient volunteered to participate in the study, and signed the Informed Consent * Age 18 <= age <= 75 years, male or female * Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi>=1.5 cm) * r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20 * At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis * Adequate organ and bone marrow fuction * No contraindications of apheresis * Expected survival time > 3 months * ECOG scores 0 - 1 Exclusion Criteria: * Have a history of allergy to cellular products * Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard * A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease * Patients with active CNS involvement * Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors * Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed * Live vaccination within 4 weeks before peripheral blood apheresis * HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers * Have a history of alcoholism, drug addiction and mental illness * Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception * Patients with severe fludarabine or cyclophosphamide hypersensitivity * The patient has a history of other primary cancers, except for the following: 1. Non-melanoma such as skin basal cell carcinoma cured by resection 2. Cured carcinoma in situ such as cervical, bladder or breast cancer * The investigators believe that there are other circumstances that are not suitable for the trial Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05812326", "Brief_Title" : "PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer", "Official_title" : "Exploratory Clinical Study of PD-1 Knockout Targeting MUC1 CAR-T Cells (AJMUC1) in the Treatment of MUC1-positive Advanced Breast Cancer", "Conditions" : ["Advanced Breast Cancer", "Breast Neoplasm Malignant Female"], "Interventions" : ["Drug: AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This exploratory clinical study aims to assess the safety and preliminary efficacy of an immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced MUC1-positive breast cancer Detailed Description This is a single-center, open-label, dose-escalation exploratory study investigating the safety,tolerability and preliminary efficacy of AJMUC1, PD-1 knockout CAR-T cells targeting aberrantly glycosylated MUC1, in the treatment of patients with advanced MUC1 positive breast cancer. The primary objective of this study is to evaluate the safety, tolerability, biological activity, and preliminary antitumor efficacy of AJMUC1. The study adopts a '3+3' dose escalation design to identify the maximum tolerated dose (MTD)/ maximum administered dose (MAD). Three doses are set: 3×105 CAR T cells/kg, 1×106 CAR T cells/kg and 3×106 CAR T cells/kg, with a total of 15 patients planned by the data cutoff date. Participants may receive one, two, three or more cycles of AJMUC1 infusion dependent on the adverse effects and potential clinical benefits.. This study is initiated by the investigators and approved by the Human Ethics Committee of Sun Yat-sen Memorial Hospital affiliated with Sun Yat-sen University. All patients have signed informed consent. #Intervention - DRUG : AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells - AJMUC1 is a genetically modified T cell therapeutic product targeting the aberrantly glycosylated MUC1 protein. CAR targeting MUC1 is introduced into autologous T cells by lentiviral vector, so that T cells expressing the receptor can recognize and kill MUC1 positive tumor cells. Preclinical studies have shown that binding of scFv targeting MUC1 to the MUC1 epitope on the surface of the target cell can induce the costimulatory CD28 and CD3ζ costimulatory domains to activate downstream signaling pathways and promote T cell activation and expansion. Activated CAR-T cells secrete a series of inflammatory cytokines and chemokines, leading to apoptosis and necrosis of target tumor cells. Following introduction of a CAR structure, the PD-1 gene of CAR-T cells is knocked out using CRISPR/Cas9, so that the CAR-T cell does not express PD-1, resulting in improved tumor killing efficiency of AJMUC due to the release of inhibition in the signaling pathway PD-1/PD-L1 in the tumor microenvironment. - Other Names : - Therapeutic T cells

#Eligibility Criteria: Inclusion Criteria: * Patient age: 18 <= age <= 70 years (including the boundary value); * Pathologically diagnosed with recurrent/metastatic breast cancer (except for intracranial metastasis), who have received at least one standard treatment regimen in the past, the disease is in a stable or progressive state, and refuses to undergo subsequent chemotherapy; * Abnormal glycosylated MUC1 expression confirmed by immunohistochemistry in tumor tissue or puncture tissue within 12 months; * Expected survival period >= 4 months; * ECOG score<=2 points; * The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; * Able to cooperate with tumor puncture; * At least one measurable lesion that meets the RECIST v1.1 criteria; * Female patients of childbearing age must not be breastfeeding, and serum or urine HCG test is negative within 72 hours before study enrollment. All subjects must use medically approved contraception during the study period and within 3 months after the end of the study. measures (eg, IUDs, birth control pills) for contraception; * Organ function and bone marrow reserve are in good condition and the following requirements must be met: (1) The absolute value of neutrophils is >=1.5×109/L; (2) Platelet count >=75×109/L; (3) Hemoglobin >=9g/dl; (4) Bilirubin value < 1.5 times the upper limit of normal (except for obstruction of the bile duct caused by tumor compression); (5) Creatinine value < 1.5 times the upper limit of normal or creatinine clearance rate >= 60ml/min; (6) ALT or AST < 2.5 times the upper limit of normal (with liver involvement < 5 times the upper limit of normal); (7) Stable coagulation function: INR<=1.5, PTT<1.2 times the upper limit of normal (except for tumor-related anticoagulation therapy). Exclusion Criteria: * Have used immunosuppressive drugs or hormones within 1 week prior to enrollment; * Patients with moderate or more moderate pleural and ascites who need catheter drainage to relieve symptoms; * Human immunodeficiency virus (HIV) positive; * Active hepatitis B or C infection; * Pregnant or lactating women; * Past or concurrent history of other malignant tumors. Excluded: Patients with basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix who have been cured at any time prior to the study; * Those with central transfer; * Serious, uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, or have any serious medical conditions that may affect the subject's safety (such as uncontrollable heart disease, high blood pressure, active or uncontrollable disease) infection, etc.); * Active autoimmune diseases (including but not limited to, systemic lupus erythematosus, Sjögren syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.); * Those with a history of organ transplantation; * Subjects whose last medication was less than 2 weeks before enrollment, or subjects who participated in other relevant clinical studies at the same time; * Those who have received gene therapy in the past; * Vaccination with live vaccine within 4 weeks prior to study; * History of myocardial infarction and severe arrhythmia within half a year; uncontrolled hypertension, coronary heart disease, stroke, liver cirrhosis, nephritis and other serious complications; * Those who have a history of psychotropic substance abuse and cannot quit or who have a history of mental disorders; * Hypersensitivity constitution, allergic to human serum albumin; * Hemorrhagic and thrombotic tendency: patients with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, abnormal coagulation function (PT>16s, APTT>43s) , TT>21s, FIB<2g/L), hereditary or acquired bleeding and thrombosis tendency to (such as hemophilia, coagulation disorder, thrombocytopenia, hypersplenism, etc.), are receiving thrombolytic or anticoagulation therapy, arterial/venous thrombotic events occurred within the previous 6 months, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; * Other severe, acute, or chronic medical or psychiatric conditions that may increase the risks associated with participation in the study or may interfere with the interpretation of the study results, in the opinion of the investigator. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04788472", "Brief_Title" : "Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL", "Official_title" : "Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients with Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia", "Conditions" : ["B-Cell Acute Lymphoblastic Leukemia, Adult"], "Interventions" : ["Drug: CAR-T cells targeting CD19 and CD22"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia Detailed Description This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult. #Intervention - DRUG : CAR-T cells targeting CD19 and CD22 - Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years; * Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia; * Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene; * Leukemia cells were CD19 and CD22 positive; * Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens; * Serum total bilirubin <= 51 mol/L, serum ALT and AST both <= 3 times the upper limit of the normal range, blood creatinine <= 176.8 mol/L; * Echocardiography showed a left ventricular ejection fraction (LVEF) >=50%; * Subjects had no active pulmonary infection and oxygen saturation >=92% without oxygen; * The prognosis for survival is more than 3 months; * ECOG score 0 <= age <= 2; * Subjects volunteered to participate in this trial and signed an informed consent form. Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial: * Those with a history of epilepsy or other central nervous system disorders; * Those with a history of prolonged QT period or severe cardiac disease; * Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known); * Those with uncontrolled active infection; * Active hepatitis B or hepatitis C virus infection; * Those who have previously used any gene therapy product; * Those with insufficient amplification (<5-fold) in response to CD3/CD28 co-stimulatory signals; * Creatinine > 2.5 mg/dl or ALT / AST > 3 times the upper limit of the normal range or bilirubin > 2.0 mg/dl; * Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment; * HIV-infected persons; * Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04888468", "Brief_Title" : "Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents", "Official_title" : "A Phase I Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL", "Conditions" : ["Acute Lymphoblastic Leukemia", "Relapsed Pediatric ALL", "Refractory Acute Lymphoblastic Leukemia"], "Interventions" : ["Biological: pCAR-19B cells"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose. Detailed Description This is a single-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion. #Intervention - BIOLOGICAL : pCAR-19B cells - Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with B-ALL，and meet one of the following conditions: 1. First-line or multiple-line salvage chemotherapy did not achieve complete remission； 2. Early relapse after complete remission (<12 months), or late relapse after complete remission (>=12 months) and complete remission has not been achieved after 1 course of treatment； 3. Relapse after autologous or allogeneic hematopoietic stem cell transplantation; * Ph+ALL patients should also receive at least two TKI treatments； * For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met： 1. Allo-HSCT takes >=6 months before pCAR-19B infusion； 2. No GVHD of grade 2 or above occurred within 2 weeks before PBMC collection; * Express CD19; * 3~21 years, no gender limit; * The expected survival time is more than 12 weeks; * KPS>60; * No serious mental disorders; * The function of important organs is basically normal: 1. Heart function: echocardiography indicates that the cardiac ejection fraction is >=50%, and the electrocardiogram has no obvious abnormalities; 2. Renal function: serum creatinine<=2.0×ULN; 3. Liver function: ALT and AST <=5×ULN; 4. Total bilirubin and alkaline phosphatase<=3×ULN ; 5. Blood oxygen saturation>92%. * Have standards for apheresis or venous blood collection, and no other cell collection contraindications; * The patient himself or his guardian agrees to participate in the clinical trial and signs the ICF, indicating that he understands the purpose and procedures of the clinical trial and is willing to participate in the research. Exclusion Criteria: * With central nervous system disease at the time of screening; * Have received CAR-T therapy or other genetically modified cell therapy; * Participated in other clinical studies within 1 month before screening; * Have received the following anti-tumor treatments before screening: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter); * Have received a live attenuated vaccine within 4 weeks before screening; * Cerebrovascular accident or seizure occurred within 6 months before signing the ICF; * Suffered from any of the following heart diseases: 1. NYHA stage III or IV congestive heart failure; 2. Myocardial infarction or CABG occurred <=6 months before enrollment; 3. Clinically significant ventricular arrhythmia, or history of unexplained syncope (except for cases caused by vasovagal or dehydration); 4. History of severe non-ischemic cardiomyopathy. * Uncontrollable infection in the 2 weeks before screening； * Active autoimmune diseases； * Patients with malignant tumors other than acute lymphoblastic leukemia within 5 years before screening, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and duct in situ after radical resection cancer； * HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive; * Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving pCAR-19B cell reinfusion; * Other situations considered by the researcher to be unsuitable to participate in the study. Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02631044", "Brief_Title" : "Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)", "Official_title" : "A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)", "Conditions" : ["Non-Hodgkin Lymphoma", "Diffuse Large B Cell Lymphoma", "Follicular Lymphoma", "Mantle-cell Lymphoma", "Primary Mediastinal B-cell Lymphoma"], "Interventions" : ["Biological: JCAR017 (lisocabtagene maraleucel) 2-dose schedule", "Biological: JCAR017 (lisocabtagene maraleucel) single-dose schedule"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment. Detailed Description This is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics (PK), and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma Grade 3B, and mantle cell lymphoma (MCL). This study will evaluate and refine the dose and schedule of JCAR017 to optimize safety and antitumor activity. A dose-confirmation group or groups will further evaluate the safety and efficacy of JCAR017 at the recommended regimen(s). Upon successful generation of JCAR017 product, participants will receive treatment with one or more cycles of JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one or two doses of JCAR017 administered by intravenous (IV) injection. The follow-up period for each participant is approximately 24 months after the final JCAR017 infusion. Long-term follow-up for survival, toxicity, and viral vector safety will continue under a separate long-term follow-up protocol per health regulatory authority guidelines, currently up to 15 years after the last JCAR017 infusion. #Intervention - BIOLOGICAL : JCAR017 (lisocabtagene maraleucel) single-dose schedule - Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection. - BIOLOGICAL : JCAR017 (lisocabtagene maraleucel) 2-dose schedule - Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon product availability, participants will receive study treatment consisting of lymphodepleting chemotherapy followed by two IV doses of JCAR017.

#Eligibility Criteria: Inclusion Criteria: * Age >=18 years * Relapsed or refractory B-cell NHL, including 1. DLBCL cohort (no longer enrolling): DLBCL, not otherwise specified (NOS; includes transformed DLBCL from indolent histology [tDLBCL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (Swerdlow 2016), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 lines of systemic therapy or after auto-HSCT. 2. MCL cohort: MCL (diagnosis must be confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization [FISH], or PCR) with relapsed or refractory disease after at least 2 prior lines of systemic MCL therapy. Subjects must have been treated with an alkylating agent, Bruton's tyrosine kinase inhibitor (BTKi), and rituximab (or other CD20-targeted agent). * PET-positive disease by Lugano classification * Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function * Adequate vascular access for leukapheresis procedure * Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy. * Participants must agree to use appropriate contraception. Exclusion Criteria: * Active central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study) * History of other primary malignancy not in remission for at least 2 years (The following are exempt from the 2-year limit: nonmelanoma skin cancer, definitively treated stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear) * Treatment with alemtuzumab within 6 months of leukapheresis or fludarabine or cladribine within 3 months of leukapheresis * Active hepatitis B, hepatitis C, or Subjects with a history of or active human immunodeficiency virus (HIV) infectionare excluded. Subjects with active hepatitis B, or active hepatitis C are also excluded. Subjects with a negative PCR assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy * Uncontrolled systemic fungal, bacterial, viral, or other infection * Presence of graft-vs-host disease (GVHD) * History of cardiovascular disease * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis * Pregnant or nursing women * Use of the following: * Therapeutic doses of corticosteroids (defined as >20 mg/day prednisone or equivalent) within 7 days of leukapheresis or 72 hours prior to JCAR017 administration. Physiologic replacement, topical, and inhaled steroids are permitted. * Low dose chemotherapy (e.g., vincristine, rituximab, cyclophosphamide <=300 mg/m2) given after leukapheresis to maintain disease control must be stopped >=7 days prior to lymphodepleting chemotherapy. * Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis. * Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks of leukapheresis. * Experimental agents within 4 weeks of leukapheresis unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis * Immunosuppressive therapies within 4 weeks of leukapheresis and JCAR017 administration (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti IL6, or anti-IL6R) * Donor lymphocyte infusions (DLI) within 6 weeks of JCAR017 administration * Radiation within 6 weeks of leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. Radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks prior to leukapheresis. * Allo-HSCT within 90 days of leukapheresis * Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JCAR017 treatment in this protocol for subjects receiving retreatment * Progressive vascular tumor invasion, thrombosis, or embolism * Venous thrombosis or embolism not managed on a stable regimen of anticoagulation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02975687", "Brief_Title" : "CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia", "Official_title" : "CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia", "Conditions" : ["Acute Lymphoblastic Leukemia, Adult B-Cell", "Acute Lymphoblastic Leukaemia Recurrent"], "Interventions" : ["Biological: CD19 CAR T cells"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In this single-center, open-label, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a 'split dose' (total dose of 5x10\^6/kg-5x10\^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL. Detailed Description In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. Patients will be diagnosed according to morphologic, immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular examination. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB,administered by i.v. injection as a using a 'split dose' (total dose of 5x10\^6/kg-5x10\^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. This protocol will be given to subjects with unmet medical needs for which there are no effective therapies known at this time. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with chemotherapy resistant or refractory CD19+ ALL. #Intervention - BIOLOGICAL : CD19 CAR T cells - CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.

#Eligibility Criteria: Inclusion Criteria: * Patients aged 18 <= age <= 70 with relapsed or refractory CD19 positive ALL(ie, >=20% blasts CD19-positive) due to receive either salvage 1 or salvage 2 therapy. Ph+ ALL patients must have failed treatment with at least 1 second generation tyrosine kinase inhibitor. * Bone marrow involvement with>=20% lymphoblasts. * Eastern Cooperative Oncology Group (ECOG) Performance status 0 <= age <= 2. * Adequate end organ function as defined by: Total bilirubin <= 1.5 x upper limit of normal（ULN）; serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) <= 2.5 x ULN; Creatinine <= 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of >= 40ml/min. * Patients should sign informed consent form. Exclusion Criteria: * Isolated extramedullary relapse. * Active central nervous system leukemia. * Prior chemotherapy within <=2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine, thioguanine, and tyrosine kinase inhibitors are permitted within 2 weeks of enrollment as maintenance or to reduce the peripheral blood blast count. Patients must have recovered from acute toxicity of all previous therapy prior to enrollment. * Prior allogeneic hematopoietic stem cell transplant (HSCT) <= 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have > grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity. * Peripheral lymphoblasts > 10,000/μl (treatment with hydroxyurea and/or steroids is permitted within 2 weeks of enrollment to reduce the WBC count). * Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease). * Major surgery within <= 4 weeks before enrollment. * Impaired cardiac function:Ejection fraction < 45 % on MUGA scan. QTc interval > 450 msec on baseline ECG (using the QTcB formula). If QTcB interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias). * Administration of live vaccine <= 4 weeks before enrollment. * Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease. * Evidence of uncontrolled current serious active infection. * Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). * Who is known human deficiency virus (HIV) positive. * Use of any other investigational agent in the last 30 days. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02658929", "Brief_Title" : "Study of bb2121 in Multiple Myeloma", "Official_title" : "CRB-401 A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Biological: bb2121"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM). Detailed Description This is a 2-part, non-randomized, open label, multi-site Phase 1 study. the study design consists of 2 parts: Part A (Dose Escalation), in which the RP2D is determined, and Part B (Expansion Cohorts), in which subjects are treated with the determined RP2D. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (bb2121). Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. All subjects who have received bb2121 infusion will be followed for up to 60 months on CRB-401. All subjects who complete the study, as well as those who withdraw from the study after receiving bb2121 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study for up to 15 years after their last bb2121 infusion, with a focus on long-term safety and efficacy. #Intervention - BIOLOGICAL : bb2121 - bb2121

#Eligibility Criteria: Inclusion Criteria: * 18 years at the time of signing informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Subjects must have measurable disease including at least one of the criteria below: Serum M-protein greater or equal to 0.5 g/dL Urine M-protein greater or equal to 200 mg/24 h Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal -Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment and refrain from tissue donation including egg donation or any other tissue/blood/organ donations, for at least 1 year following bb2121 infusion. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study. All sexually active males subjects must refrain from tissue donation including egg donation or any other tissue/blood/organ donations, for at least 1 year following bb2121 infusion. Part A: Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have 'double refractory' disease to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents * Part B: Diagnosis of MM with relapsed or refractory disease with previous exposure to PI (e.g., bortezomib or carfilzomib), IMiDs (e.g., lenalidomide or pomalidomide), and daratumumab, and refractory (based on IMWG criteria) to their last line of therapy Exclusion Criteria: * Subjects with known central nervous system disease * Inadequate hepatic function * Inadequate renal function * Inadequate bone marrow function * Presence of active infection within 72 hours * Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions * Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission * Subjects with a history of class III or IV congestive heart failure or non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 6 months * Known human immunodeficiency virus (HIV) positivity * Subjects who have plasma cell leukemia or clinically significant amyloidosis * Pregnant or lactating women Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No