drugset / Trial / NCT04893915
Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS
Non-randomizedSequentialOpen-labelTreatment
Summary
Patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) will receive lymphodepleting chemotherapy (Flu/Cy) and two infusions of cytokine-induced memory-like NK cells at the previously defined maximum tolerated dose (MTD), fourteen days apart. Low dose rhIL-2 will be administered to patients for in vivo expansion following cell infusion. Patients will be assessed for anti-leukemic efficacy and safety. Re-infusion of patients who relapsed after clinical response will be considered.
Timeline
- Start
- 2022-06-30
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CIML-NK Cells | Cell therapy | 2e+07 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | aldesleukin | Protein / enzyme biologic | — | — |