eligibility_summary
Consent. Adults ≥18 with CD33+ AML (relapsed, refractory, or high risk), KPS ≥70, adequate organs (bili ≤2 [≤3 Gilbert], AST/ALT ≤3×ULN, CrCl ≥60, LVEF ≥50%, O2 >92%), contraception/neg pregnancy test, and original alloSCT donor (HIV–, KPS ≥70). Exclude alloSCT <6 mo, active immunosuppression/GVHD, other investigational therapy, systemic antifungals, ≥G2 myelofibrosis, unstable arrhythmia, bleeding disorder, stroke/ICH ≤6 mo, other active cancer, uncontrolled illness/infection, HIV/HBV/HCV, pregnancy/breastfeeding, or noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Anti‑CD33 CAR T cells (biological, gene‑modified T‑cell therapy) using lentivirally transduced, donor‑derived (allogeneic) T cells from the patient’s prior allo‑HSCT donor, infused after lymphodepletion. Cetuximab may be used as a safety “off switch.” Mechanism of action: CAR uses a CD33‑specific scFv with CD8 hinge, 4‑1BB costimulatory and CD3ζ signaling domains to activate T‑cell cytotoxicity against CD33+ cells, lymphodepletion reduces host lymphocytes to enhance CAR T expansion, truncated EGFR (EGFRt) tag enables cetuximab‑mediated ablation of CAR T cells. Cells/pathways targeted: CD33 on AML blasts and myeloid progenitors (impacting hematopoiesis), T‑cell activation via 4‑1BB/CD3ζ, EGFRt/cetuximab axis for reversible CAR T control.