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

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.

Key Inclusion Criteria:Provision of signed and dated informed consent form (ICF)≥18 years oldDiagnosis of r/r AMLEastern Cooperative Oncology Group (ECOG) performance status ≤1Adequate organ function as defined in the protocolDonor specific antibody (DSA) to QN-030a: MFI <= 2000Key Exclusion Criteria:Allergic to drug used in this studyAccept 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 therapyAcute Promyelocytic Leukemia (APL)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