eligibility_summary
Eligible: Adults with relapsed/refractory, non‑proliferative AML, ≤3 prior lines, no effective therapy, ECOG 0–1, transplant‑fit, adequate organ function, contraception. Exclude: APL, PET‑CT–inactive EMD, prior CAR‑T, allo‑SCT <100 d or active GVHD, CNS involvement, HIV, live vaccine <4 wks, active HBV/HCV, primary immunodeficiency/autoimmunity, CB‑012 allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests CB-012, a CRISPR-edited, allogeneic (off‑the‑shelf) CAR‑T cell therapy targeting CLL‑1 (CLEC12A). Mechanism: the CAR redirects donor T cells to bind CLL‑1 on AML cells, activating T‑cell signaling and cytotoxicity to lyse CLL‑1–positive blasts. Lymphodepletion uses cyclophosphamide (alkylating chemotherapy) and fludarabine (purine antimetabolite) to reduce host lymphocytes and enhance CAR‑T expansion/persistence. Targets: CLL‑1 on myeloid leukemia cells, pathway is CAR‑mediated T‑cell activation and killing. Phase 1 dose‑escalation/expansion, study terminated (sponsor reprioritization).