drugset / Trial / NCT05948033
CD70 Targeted CAR-T Cells in CD70 Positive Relapsed/Refractory Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Timeline
- Start
- 2023-07-15
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD70-targeting CAR-T cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | CD70-targeting CAR-T cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | CD70-targeting CAR-T cells | Cell therapy | 1e+07 cells/kg | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |