eligibility_summary
Eligibility: Adults 18–70 with refractory AML (per Chinese guideline), EX02+ leukemia cells, ECOG 0–2, Hgb>60 g/L, CD3+>0.5×10^9/L, platelets>30×10^9/L, negative pregnancy test/contraception, informed consent. Exclude: active hepatitis/HIV/uncontrolled infection, AIDS or chronic immunosuppression, serious cardiac disease (NYHA III–IV, recent MI/CABG, arrhythmia, cardiomyopathy, LVEF<45%), pregnancy/lactation, severe liver/kidney dysfunction, severe drug allergy, post‑HSCT unless off IS ≥6 wks, no GVHD, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Early Phase 1, single-arm EX02 CAR-T therapy for relapsed/refractory AML. Intervention: Autologous, gene‑modified CAR-T cell product (biologic). Patients undergo leukapheresis, lymphodepletion with cyclophosphamide (250 mg/m2/day) and fludarabine (25 mg/m2/day) for 3 days, then a single IV infusion of EX02 CAR-T cells (1×10^6 cells/kg), with standard premedication. Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor recognizing the EX02 antigen on AML cells, CAR engagement triggers T‑cell activation (via CAR signaling domains), cytokine release, and perforin/granzyme‑mediated cytotoxicity, leading to targeted leukemia cell killing and in vivo expansion/persistence of CAR-T cells. Targets: EX02-positive AML blasts (surface EX02 expression required). Pathways: CAR-mediated T‑cell activation (CD3ζ/costimulatory signaling), adaptive cytotoxic immune response, lymphodepletion reduces host lymphocytes to enhance CAR-T expansion.