eligibility_summary
Adults ≥18, HLA‑B/C matched, CD123+ AML. Ph1a: R/R, no curative options. Ph1b: ≤3rd relapse, BM blasts ≤30% or 30–40% twice, no hyperproliferation. MRD+ eligible per guidelines with prior/ineligible allo‑HSCT and sponsor OK. ECOG 0–1, ≥3‑mo, adequate organs/cardiac, ≥45 kg, consent/BC. Exclude APL, CNS/extramedullary AML, major cardiac/pulm/neuro disease, recent thrombosis/infection/HSCT/other therapy, autoimmune on IS, pregnancy, HIV/HTLV/HBV/HCV, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05949125: Phase 1, open-label study in CD123+ relapsed/refractory AML. Interventions: 1) Allo-RevCAR01-T: an allogeneic, gene-edited T‑cell therapy engineered with a “reverse,” universal CAR that displays an extracellular peptide epitope (cellular therapy). 2) R‑TM123: a recombinant antibody‑derived, bispecific adapter protein that binds the RevCAR epitope and CD123, bridging tumor and T cell to trigger CAR signaling (biologic). Dosing: single IV infusion of Allo‑RevCAR01‑T plus continuous IV R‑TM123, lymphodepletion with fludarabine and cyclophosphamide (chemotherapy). Targeted cells/pathways: CD123‑expressing AML blasts, activation of cytotoxic T‑cell effector function via CAR signaling, enabling dose‑tunable, modular engagement of CD123+ malignant cells.