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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Terminated

Phase 1

Conditions

Minimal Residual Disease

Treatments

Drug: QN-030a

Drug: Fludarabine

Drug: Cyclophosphamid

Drug: Cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT05601830

IIT2022030

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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