eligibility_summary
Eligible: adults 18–70 with R/R AML (2022 WHO) expressing CLL1 (FCM ≥70% or IHC ≥50%), ECOG 0–2, life expectancy >12 wks, venous access/leukapheresis & organ function (CrCl ≥60 or Cr ≤2.5×ULN, EF >50%, SpO2 >92%, Tbili ≤3×ULN, ALT/AST ≤3×ULN), consent. Exclude: APL, recent other cancers, uncontrolled infections (HBV/HCV/HIV/syphilis), major CV/pulmonary/CNS disease, recent thromboembolism, steroids, recent PD-1/PD-L1, pregnancy, prior CAR‑T/gene therapy, post‑allo‑HSCT, allergies, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm, dose-escalation trial of anti‑CLL‑1 CAR‑NK cells for relapsed/refractory AML. Intervention: gene‑modified cellular immunotherapy—natural killer cells engineered with a chimeric antigen receptor targeting CLL‑1 (CLEC12A), source may be autologous or donor. Single infusion at 5×10^6 to 4×10^7 CAR‑NK cells/kg. Mechanism: CAR engagement of CLL‑1 on leukemia cells activates NK cytotoxicity (perforin/granzyme, cytokines) to kill AML blasts and leukemia stem/progenitor cells, with relative sparing of normal hematopoietic stem cells. Targets/pathways: CLL‑1 antigen on AML cells, NK CAR signaling and innate effector pathways. Primary focus: safety, tolerability, PK, preliminary efficacy.