CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；
2. Expected survival time ≥12 weeks;
3. Adequate hematological, renal and liver function;
4. Subjects understand and voluntarily sign the informed consent form.

Key Exclusion Criteria:

1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
2. Cyclophosphamide or fludarabine is contraindicated for subjects ;
3. Active central nervous system (CNS) involvement by malignancy；
4. Active infection.