drugset / Trial / NCT07259070
Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma
Phase 1/2
Recruiting
20 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Hebei Taihe Chunyu Biotechnology Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD). The secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma. The study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.
Timeline
- Start
- 2025-11-29
- Primary completion
- 2029-11-28
- Completion
- 2029-11-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAFFR CAR-T | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | BAFFR CAR-T | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | BAFFR CAR-T | Cell therapy | 3e+06 cells/kg | Intravenous |