drugset / Trial / NCT05963217
Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed or Refractory CD19+ B-cell Lymphoma, CLL/SLL
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1/1b, open-label, dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor (CAR) (TBI-2001) for relapsed or refractory CD19+ B-cell lymphoma Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).
Timeline
- Start
- 2023-07-26
- Primary completion
- 2028-06-30
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TBI-2001 | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | TBI-2001 | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | TBI-2001 | Cell therapy | 3e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |