Natural Killer(NK) Cell Therapy in r/r AML

Zhejiang University

Status and phase

Enrolling

Phase 1

Conditions

AML, Adult

Treatments

Drug: QN-030a

Drug: Cytarabine

Drug: Cyclophosphamid

Drug: Fludarabine

Drug: VP-16

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05665114

QN030aAL

Details and patient eligibility

About

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.

Enrollment

18 estimated patients

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
Diagnosis of r/r AML
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 drugs/therapies within certain time of day 0 (first QN-030a dose infusion), time window and drug defined in the protocol.
received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
Acute Promyelocytic Leukemia (APL)
Central nervous system Leukemia.
Uncontrolled, active clinically significant infection
Clinically significant cardiovascular disease as defined in the protocol
Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
History of central nervous system (CNS) disease such as stroke, epilepsy.
Females are pregnant or lactating
Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject