drugset / Trial / NCT03666000
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.
Timeline
- Start
- 2019-03-11
- Primary completion
- 2027-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azer-cel | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | Azer-cel | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | Azer-cel | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | Azer-cel | Cell therapy | 6e+06 cells/kg | Intravenous |
| Subject | Azer-cel | Cell therapy | 5e+08 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | IL-2 | Protein / enzyme biologic | — | — |