drugset / Trial / NCT05744440

Safety and Efficacy of Allogenic NK Cells in Combination With Chemotherapy in the Treatment of r/r AML After Allo-HSCT

NCT05744440 ↗

Phase 0 Unknown 12 enrolled Xuzhou Medical University
NaSingle-groupOpen-labelTreatment

Summary

This is an open label, single-arm, Phase I study to evaluate the efficacy and safety of allogenic natural killer(NK) cells in subjects with refractory or relapsed AML after allogeneic hematopoietic stem cell transplantation(allo-HSCT). A leukapheresis procedure will be performed to manufacture NK cells. Prior to allogenic NK cells infusion subjects will receive chemotherapy with azacitidine.

Timeline

Start
2023-03-01
Primary completion
2025-05
Completion
2025-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogenic NK cells Cell therapy 1e+07 cells/kg Other
Subject Allogenic NK cells Cell therapy 5e+07 cells/kg Other