drugset / Trial / NCT07591649
Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multi-institutional Phase I/II study of an allogeneic KIR-HLA mismatched NK cell infusion (AdaptNK) and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy \[cyclophosphamide (CY)/fludarabine (FLU)\] in patients with relapsed or refractory acute myelogenous leukemia (AML). AdaptNK is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype.
Timeline
- Start
- 2026-05-08
- Primary completion
- 2030-03-01
- Completion
- 2035-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AdaptNK | Cell therapy | 1e+08 cells | Intravenous |
| Subject | AdaptNK | Cell therapy | 2.4e+08 cells | Intravenous |
| Subject | AdaptNK | Cell therapy | 8e+08 cells | Intravenous |
| Subject | AdaptNK | Cell therapy | 2.4e+09 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Background | Fludarabine | Small molecule | 25 mg/kg | — |
| Background | aldesleukin | Protein / enzyme biologic | 6e+06 iu | Subcutaneous |