NCT05744440

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

Early Clinical Study of Allogenic NK Cells (JD002) in Combination With Chemotherapy in the Treatment of Relapsed or Refractory(r/r) Acute Myeloid Leukemia(AML) After Allo-HSCT

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of allogenic NK cells in subjects with refractory or relapsed AML after allo-HSCT. A leukapheresis procedure will be performed to manufacture NK cells. Prior to allogenic cells infusion subjects will receive chemotherapy with azacitidine. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable dose(MTD) and recommended phase 2 dose(rp2d) were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	allogenic NK cells	The relapsed/refractory AML after allo-HSCT patients will receive allogenic NK cells infusion up to 2 dose levels (1x10\^7/kg, 5x10\^7/kg) after chemotherapy with azacitidine

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-02-27
• Last updated: 2023-02-27

Locations

1 site across 1 country: China