eligibility_summary
Eligibility: Adults ≥18 with r/r AML, CLL1+ blasts, ECOG 0–1, life expectancy >12 wks, adequate renal/liver/coagulation function, DSA negative (MFI≤2000), negative pregnancy test, consent. Exclude: recent steroids/anticancer tx/RT/DLI/IT/CAR‑T/NK, prior allo‑SCT, recent/planned vaccines, CNS leukemia or APL, other active cancers, autoimmune/CNS disease, serious CV/pulmonary or uncontrolled infection (incl. HIV/HBV/HCV), unresolved tox, major surgery, pregnancy, substance abuse, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label FIH study of an allogeneic iPSC-derived CAR-NK cell therapy targeting CLL1 (CLEC12A) in relapsed/refractory AML. Interventions: CLL1 CAR‑NK cell infusion (gene-modified adoptive cellular immunotherapy) after lymphodepletion with cyclophosphamide (alkylating agent), fludarabine (purine analog antimetabolite), and VP‑16/etoposide (topoisomerase II inhibitor). Mechanism: NK cells engineered with a chimeric antigen receptor recognize CLL1 on AML blasts and kill via NK cytotoxicity (perforin/granzyme), aiming to eradicate CLL1+ leukemic cells while sparing normal hematopoietic stem cells that lack CLL1. Targeted cells/pathways: CLL1/CLEC12A surface antigen on myeloid leukemia cells, activation of NK effector pathways and depletion of CLL1+ AML blasts.