An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies

KM-PBC920

It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.

2023-07-01

2024-06-30

2025-06-30

Recruiting

Early phase I

60

Key Inclusion Criteria: 1. A definite diagnosis of relapsed/refractory B-cell malignancies; 2. Male or female, aged 2-75 years; 3. Confirmed detectable disease； 4. Expected survival time \>12 weeks; 5. Eastern cooperative oncology group (ECOG) score is 0-2; 6. Adequate liver , kidney and cardiopulmonary function; 7. 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; 8. Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Key Exclusion Criteria: 1. Presence of other concurrent active malignancy; People with severe mental disorders; 2. 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; 3. Acute GVHD of grade II-IV or extensive chronic GVHD; 4. 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; 5. 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; 6. 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; 7. 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); 8. Had undergone other clinical trials in the 4 weeks prior to participating in this trial; 9. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 10. For patients contraindicated with cyclophosphamide and fludarabine chemotherapy; 11. 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; 12. Receiving donor lymphocyte infusion within 6 weeks before enrollment; 13. Pregnant and lactating women; 14. Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will receive one of the three doses of 0.5-2\\*10\\^6/kg, 3-4\\*10\\^6/kg, 5-6\\*10\\^6/kg.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-07-11