A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies
B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors
About this trial
This is an interventional treatment trial for B-Cell Leukemia focused on measuring B Cell, CAR-T, CD19, Leukemia, Lymphoma
Eligibility Criteria
Key Inclusion Criteria: A definite diagnosis of relapsed/refractory B-cell malignancies; Male or female, aged 2-75 years; Confirmed detectable disease; Expected survival time >12 weeks; Eastern cooperative oncology group (ECOG) score is 0-2; Adequate liver , kidney and cardiopulmonary function; Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up; Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Key Exclusion Criteria: Presence of other concurrent active malignancy; People with severe mental disorders; History of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome; Acute GVHD of grade II-IV or extensive chronic GVHD; Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment; The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters; Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; Patients with severe history of allergy or allergic constitution; A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis); Had undergone other clinical trials in the 4 weeks prior to participating in this trial; Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; For patients contraindicated with cyclophosphamide and fludarabine chemotherapy; Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events; Receiving donor lymphocyte infusion within 6 weeks before enrollment; Pregnant and lactating women; Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.
Sites / Locations
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaRecruiting
Arms of the Study
Arm 1
Experimental
OlyCAR-019 Cell Infusion
OlyCAR-019 cell infusion will be administered by vein after short-time manufacture.