drugset / Trial / NCT04893915

Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS

NCT04893915

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

EvaluationDrugModalityDoseRoute
Subject CIML-NK Cells Cell therapy 2e+07 cells/kg
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule
Background aldesleukin Protein / enzyme biologic