eligibility_summary
Eligible: AML patients (>6 months) with CLL-1/CD123 and/or CD33+ blasts, KPS>80, life expectancy >3 months, adequate organ function (EF≥50%, O2≥90%, creat ≤2.5×ULN, AST/ALT ≤3×ULN, bilirubin ≤2.0 mg/dL), Hgb ≥80 g/L, no cell-separation contraindications, consent. Exclude: severe illness, uncontrolled infection, active bacterial/fungal/viral infection, HIV/HBV/HCV, pregnant/nursing, systemic steroids <1 week, noncompliance risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06420063 tests EB-BH2025, an autologous chimeric antigen receptor T-cell (CAR‑T) therapy directed at CD33 and CD123, given sequentially/combined in relapsed/refractory AML. Mechanism: patient T cells are genetically engineered to express CARs that bind CD33 (Siglec‑3) and CD123 (IL‑3Rα), triggering T‑cell activation and cytotoxic killing of antigen‑positive leukemia cells and enabling in vivo expansion/persistence. Preconditioning uses fludarabine (purine analog, lymphodepleting) and cyclophosphamide (alkylating agent, lymphodepleting) to enhance CAR‑T engraftment. Targets: CD33+ and CD123+ AML blasts and leukemic stem/progenitor cells, these myeloid lineage antigens are the primary pathways engaged via surface antigen recognition. Primary focus: safety, efficacy, and CAR‑T persistence.