eligibility_summary
Adults (≥18) with r/r AML or AML MRD, ECOG≤1, life expectancy >12 weeks. Cohort 1: CLL1+ and CD33+ blasts, Cohort 2: CD33+, adequate renal/hepatic/coagulation, negative pregnancy test, DSA MFI≤2000. Exclude: allergies, recent anti-cancer therapy/vaccines, prior allo-SCT, CNS leukemia/APL, other cancers (unless CR>5y), autoimmune/CNS disease, major CV/pulmonary disease, active infections (HIV/HBV/HCV), substance abuse, unresolved ≥G3 tox, recent surgery, pregnancy, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, first-in-human, open-label trial of iPSC-derived natural killer (NK) cell therapies for relapsed/refractory AML or AML MRD. Interventions: (1) CD33/CLL1 dual CAR-NK cells (cellular gene therapy) and (2) CD33 CAR-NK cells (cellular gene therapy), both engineered with chimeric antigen receptors to bind CD33 and/or CLL1 (CLEC12A) on AML blasts and kill via NK cytotoxic pathways (perforin/granzyme, cytokine release). (3) “Super NK” cells (iPSC-derived, enhanced/activated NK cellular therapy) for MRD. Conditioning: cyclophosphamide (alkylating agent), fludarabine (purine analog), and cytarabine (antimetabolite) as lymphodepleting chemotherapy to aid NK engraftment/expansion and reduce leukemia burden. Targets: AML blasts expressing CD33 and/or CLL1, antigen-directed NK activation and innate immune cytotoxicity to clear bulk disease and MRD.