drugset / Trial / NCT03766126
Lentivirally Redirected CD123 Autologous T Cells in AML
Non-randomizedSequentialOpen-labelTreatment
Summary
Phase 1 open-label study to estimate the safety, manufacturing feasibility, and efficacy of intravenously administered, lentivirally transduced T cells expressing anti-CD123 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains in Acute Myeloid Leukemia (AML) subjects.
Timeline
- Start
- 2018-12-06
- Primary completion
- 2026-03-05
- Completion
- 2026-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CART123 cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CART123 cells | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | CART123 cells | Cell therapy | 5e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |