drugset / Trial / NCT06006403
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Phase 1/2
Recruiting
36 enrolled
Chongqing Precision Biotech Co., Ltd
Shanxi Bethune Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed/refractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed/refractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.
Timeline
- Start
- 2023-08-31
- Primary completion
- 2025-12-31
- Completion
- 2026-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD123 targeted CAR-NK cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CD123 targeted CAR-NK cells | Cell therapy | 1e+07 cells/kg | Intravenous |