eligibility_summary
Eligible: consented patients aged 1–18 with AML expressing CLL1 and CD33 (incl. secondary AML) or relapse post-therapy without CR after 1 chemo cycle, adequate organ function (ALT/AST <3×ULN, bilirubin ≤34.2 μmol/L, creatinine <220 μmol/L, SpO2 ≥95%, LVEF ≥40%), good peripheral venous access, ECOG 0–2. Exclude: recent uncontrolled infection, active HBV/HCV, HIV/syphilis, other primary tumors, serious autoimmune/immunodeficiency, biologic allergy, pregnancy/lactation, or other concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CLL1/+CD33 CAR-T—an autologous, genetically engineered chimeric antigen receptor T‑cell therapy (biological) given as a single IV infusion (1.0–2.5×10^6 CAR+ T cells/kg). Mechanism of action: Patient T cells are modified to express CARs recognizing CLL1 and CD33, antigen binding triggers T‑cell activation, cytokine release, and cytotoxic killing of target cells independent of the native TCR. Targets (cells/pathways): Surface antigens CLL1 (CLEC12A) and CD33 on AML blasts and leukemic stem/progenitor myeloid cells, engages CAR signaling pathways in T cells to eliminate AML cells expressing either antigen. Study aim: Assess safety and efficacy in refractory/relapsed AML (single-arm, open-label, pediatric/adolescent). Status: Withdrawn due to sponsor strategy change.