Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
Summary
1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 3. Participant Intervention: * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Timeline
- Start
- 2023-10-01
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19 CAR.p40-T | Cell therapy | 0.5 cells/kg | Intravenous |
| Subject | CD19 CAR.p40-T | Cell therapy | 2 cells/kg | Intravenous |
| Subject | CD19CD20-CAR.p40-T | Cell therapy | 0.5 cells/kg | Intravenous |
| Subject | CD19CD20-CAR.p40-T | Cell therapy | 2 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |