drugset / Trial / NCT05110742
Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances
Non-randomizedSequentialOpen-labelTreatment
Summary
To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.
Timeline
- Start
- 2024-04-22
- Primary completion
- 2027-12-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAR.5/IL15-transduced CB-NK cells | Cell therapy | 1e+07 cells | Intravenous |
| Subject | CAR.5/IL15-transduced CB-NK cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | CAR.5/IL15-transduced CB-NK cells | Cell therapy | 1e+09 cells | Intravenous |
| Subject | CAR.5/IL15-transduced CB-NK cells | Cell therapy | 1e+10 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |