eligibility_summary
Part A (collection): CD371+ AML any status, age ≥1y (≥10 kg peds), allo-HCT ok if ≥100 d, no GVHD, off IS ≥30 d. Exclude: pregnancy/lactation, active CNS leukemia, uncontrolled illness or cardiac dysfunction, HIV/HBV/HCV, consent issues. Part B (treatment): R/R CD371+ AML, adequate PS and organ function, prior allo-HCT ok, HSCT donor required. Exclude: bridging chemo <1 wk (HU ok), CNS disease, isolated EMD, no donor, uncontrolled illness/cardiac disease, HIV/HBV/HCV, active 2nd malignancy, pregnancy, consent issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD371-YSNVZ-IL-18 CAR T cells (ArmoRed), an autologous, genetically modified CAR T-cell therapy given after lymphodepleting chemotherapy. Mechanism of action: The CAR recognizes CLEC12A (CD371/CLL-1) on AML cells, activating T-cell cytotoxicity via CAR signaling (CD3ζ with costimulation) to kill leukemic cells. The “armored” design secretes IL-18, which enhances CAR T expansion/persistence and Th1 polarization, boosts IFN-γ–driven immunity, and recruits/activates innate cells (NK cells, macrophages), broadening anti-leukemia activity. Targets: CD371+ AML blasts and leukemic stem cells, immune pathways include CAR T-cell activation and the IL-18/IL-18R–MyD88–NF-κB axis. Phase: 1, dose-escalation in relapsed/refractory AML.