eligibility_summary
Eligibility: ≥12 yrs with relapsed/refractory AML, FLT3+ by flow, ≥5% blasts, failed/ineligible for standard options, KPS/Lansky ≥50, adequate organ function, and an identified allogeneic donor/cord source. Exclude: APL, active CNS AML, recent HSCT (auto <6 wks, allo <3 mo) or GVHD, uncontrolled infection/CNS disease/cardiac risk/recent thrombosis, HIV/HBsAg+/active HCV, recent live vaccine/surgery/immunomodulators/anticancer therapy, prior CAR-T, significant autoimmune/liver disease, indwelling drains, pregnancy, contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: AMG 553, a FLT3-directed CAR-T cell therapy (gene‑modified cellular immunotherapy). Mechanism of action: patient T cells are engineered to express a chimeric antigen receptor that binds FLT3 (CD135) on leukemia cells, activating T‑cell effector functions (cytokine release, perforin/granzyme–mediated cytotoxicity) to eliminate FLT3+ blasts. Targets: FLT3-positive myeloblasts in relapsed/refractory AML, FLT3 receptor tyrosine kinase pathway on malignant myeloid cells, engages T‑cell activation pathways via CAR signaling. Design: Phase 1, single-arm dose escalation to determine MTCD/RP2CD. Status: Withdrawn by sponsor after strategy reassessment.