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Recruiting
NCT05601830
Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease
Conditions: Minimal Residual Disease
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 18
Sponsor: Institute of Hematology & Blood Diseases Hospital
Location: China
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.
Eligibility Criteria
Key Inclusion Criteria:Provision of signed and dated informed consent form(ICF)≥18 years oldSubject diagnosed of AML MRD.Eastern 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 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 therapyAcute Promyelocytic Leukemia (APL)Active central nervous system Leukemia.Uncontrolled, active clinically significant infectionClinically significant cardiovascular disease as defined in the protocolHistory of central nervous system (CNS) disease such as stroke, epilepsy.Females are pregnant or lactatingKnown HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infectionInvestigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
Source: ClinicalTrials.gov (NCT05601830). StuddyBuddy aggregates publicly available trial information.