eligibility_summary
Subjects: 18–60, R/R AML or CMML, ECOG 0–2, marrow LILRB4+, adequate organ function, consent/contraception. Exclude: recent CAR‑T/other trials, significant CV disease, active HBV/HCV/syphilis, autoimmune disease/HIV/immunodeficiency, other active cancer, CNS disease/CNS leukemia, transplant <6 mo or GVHD, recent immunosuppressants/chemo/biologics, psych/substance issues, pregnancy/lactation. Donors: ≥12, ≥haplo HLA match, good access, consent, exclude infections, HBV/HCV/HIV/syphilis, anemia/thrombocytopenia, CV disease, psych issues, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm study in R/R AML/CMML evaluating LILRB4 STAR‑T cells. Intervention: LILRB4 STAR‑T cells (cellular gene therapy, patient/donor T cells transduced via lentivirus to express a synthetic antigen receptor to LILRB4/ILT3) given after lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog). Mechanism: engineered receptor binding to LILRB4 on leukemic monocytic/myeloid cells activates T‑cell cytotoxicity (perforin/granzyme, cytokines) to eliminate LILRB4+ blasts and immunosuppressive myeloid cells, lymphodepletion promotes CAR‑T expansion/persistence. Targets: LILRB4 (ILT3) on AML/CMML cells, T‑cell activation pathways. Primary endpoints: safety (DLT, AE, SAE, CRS, ICANS), secondary: responses and PK/PD/ADA.