eligibility_summary
Inclusion: Adults 18–70 with WHO-AML, 60–100 days post allo-HSCT, BM blasts <5%, full donor chimerism, plus ≥1 relapse risk (refractory to 2 inductions, prior MDS/MPN, WBC ≥100+CNSL, MRD+, active disease pre-HSCT, high-risk cytogenetics). ECOG 0–1, tox <G2, adequate organs, LVEF ≥45%, neg pregnancy test/contraception. Exclusion: relapse/MRD+, severe pulmonary/cardiac/neurologic/CNS disease, HBV/HCV/HIV/CMV/syphilis, other organ Tx/maintenance Rx, severe GvHD, life expectancy <3 mo, recent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05858814 tests RC1012, an off-the-shelf allogeneic double‑negative T‑cell (DNT, mature CD3+CD4−CD8− T cells) therapy sourced from healthy donors (biological/cell therapy). Mechanism of action: donor DNTs exert MHC‑independent cytotoxic activity against AML blasts, aiming to enhance graft‑versus‑leukemia immune surveillance after allo‑HSCT and reduce relapse risk. Targets: malignant AML blasts/minimal residual disease in bone marrow post‑transplant, engages T‑cell cytotoxic immune pathways. Dosing: 1.0×10^8 or 1.5×10^8 cells/kg on Days 0, 28, and 56 (Phase I dose escalation, then Phase II expansion). Primary focus: safety and tolerability, preventive setting after allo‑HSCT in high‑risk AML.