Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia

This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.

Key Inclusion Criteria:Provision of signed and dated informed consent form (ICF)≥18 years oldDiagnosis of r/r AMLSubjects with CD33 positive leukemia cellsEastern Cooperative Oncology Group (ECOG) performance status ≤1Adequate organ function as defined in the protocolDonor specific antibody (DSA) to QN-023a: MFI <= 2000Key Exclusion Criteria:Allergic to drug used in this studyAccept other anti-tumor drug within certain time of day 0 (first QN-023a 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 therapyAcute Promyelocytic Leukemia (APL)Active central nervous system Leukemia.Uncontrolled, active clinically significant infectionClinically significant cardiovascular disease as defined in the protocolKnown HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infectionHistory of central nervous system (CNS) disease such as stroke, epilepsy.Females are pregnant or lactatingInvestigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject