drugset / Trial / NCT05563545
Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia
Phase 1
Completed
2 enrolled
Shanghai Simnova Biotechnology Co.,Ltd.
Hebei Yanda Ludaopei Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single arm clinical study to observe the safety ，dose tolerance and pharmacokinetic characteristics of CAR NK-CD19 in patients with recurrent or refractory CD19 positive acute lymphoblastic leukemia, and preliminarily evaluate the effectiveness, the immunogenicity of the product and the correlation between the changes of cytokines after infusion and CRS , ICANS.
Timeline
- Start
- 2022-07-21
- Primary completion
- 2022-11-25
- Completion
- 2022-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAR-NK-CD19 Cells | Cell therapy | 1e+07 cells/kg | — |
| Subject | CAR-NK-CD19 Cells | Cell therapy | 2e+07 cells/kg | — |
| Subject | CAR-NK-CD19 Cells | Cell therapy | 3e+07 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |