drugset / Trial / NCT05673447
The Study of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10\^8 cells, 1×10\^9 cells, 1.5×10\^9 cells). The primary endpoints are DLT, MTD. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR).
Timeline
- Start
- 2023-03-01
- Primary completion
- 2023-12-30
- Completion
- 2024-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CD19 CAR NK cells | Cell therapy | 6e+08 cells | — |
| Subject | anti-CD19 CAR NK cells | Cell therapy | 1e+09 cells | — |
| Subject | anti-CD19 CAR NK cells | Cell therapy | 1.5e+09 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |