Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease

• Status: Recruiting
• Trial end date: 2025-10-21
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in Acute Myeloid Leukemia Minimal Residual Disease(AML MRD).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-020a in patients with AML MRD, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Cyclophosphamide; Cytarabine; Fludarabine

Criteria

Key Inclusion Criteria:

• Provision of signed and dated informed consent form(ICF)

• ≥18 years old

• Subject diagnosed of AML MRD.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Adequate organ function as defined in the protocol

• Donor specific antibody (DSA) to QN-030a: MFI ≤ 2000

Key Exclusion Criteria:

• Allergic to drug used in this study

• Accept other anti-tumor drug within 2 weeks of day 0 (first QN-030a dose infusion)

• Prior allogeneic hematopoietic stem cell transplant (HSCT) within 6 months of Day 0, received systemic immunosuppressive therapy within 7 days of Day 0, or likely to require systemic immunosuppressive therapy

• Acute Promyelocytic Leukemia (APL)

• Active central nervous system Leukemia.

• Uncontrolled, active clinically significant infection

• Clinically significant cardiovascular disease as defined in the protocol

• History of central nervous system (CNS) disease such as stroke, epilepsy.

• Females are pregnant or lactating

• Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection

• Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject