eligibility_summary
Eligibility: Adults 18–75 with recurrent/refractory t(8,21) AML carrying AML1-ETO (RUNX1-RUNX1T1), HLA-A11:01 or A02:01, persistent/MRD+ after ≥3 cycles or progression after adequate therapy, ECOG ≤1, expected survival ≥3 months, able to consent, fit for PBMC collection. Exclude: AML1-ETO–negative, active infection, significant hepatic/renal/cardiac disease, HIV, long-term anticoagulants/antiplatelets, recent RT, substance/psychiatric issues, other trials, pregnancy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: Targeted AML1-ETO neoantigen cytotoxic T cells (CTL) — a biological, adoptive T‑cell therapy. Donor PBMC–derived, partially HLA‑matched CTLs are expanded to recognize AML1‑ETO (RUNX1‑RUNX1T1) fusion–derived peptides, they kill leukemia cells via TCR-mediated, HLA-A11:01 or HLA-A02:01–restricted recognition and perforin/granzyme cytotoxicity. Preconditioning drugs: Decitabine (drug, hypomethylating DNMT inhibitor) to enhance antigen/HLA expression, Cyclophosphamide (drug, alkylator) for lymphodepletion/immunosuppression, Liposomal mitoxantrone (drug, topoisomerase II inhibitor) for cytoreduction. Targets/cells/pathways: t(8,21) AML blasts expressing AML1‑ETO, antigen presentation via HLA class I, TCR signaling and CTL effector pathways, epigenetic modulation (decitabine). Design: single‑arm, Early Phase 1 dose escalation/expansion (5×10^7 or 1×10^8 CTLs).