eligibility_summary
Adults 18–75 with R/R mesothelin‑positive solid tumors post standard therapy, ≥1 measurable lesion, ECOG 0–1, and adequate organ function, contraception required. Exclude pregnancy/lactation, active HBV/HCV/HIV/syphilis, unresolved toxicities, prior allo‑transplant or anti‑mesothelin CAR‑T, recent major surgery, unstable CNS mets, serious infection, cardiac, autoimmune or immunodeficiency disorders, bleeding risk, severe drug allergy, recent live vaccine/trial, major neuropsychiatric disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Anti-mesothelin CAR-T cells (autologous, genetically modified T cells, biological/cell therapy) infused IV after lymphodepletion with fludarabine (purine analog antimetabolite chemotherapy) and cyclophosphamide (alkylating chemotherapy). Mechanisms: CAR-Ts express an anti-MSLN CAR (scFv with CD3ζ ± costimulatory domains) that binds mesothelin on tumor cells, activating T-cell signaling, cytokine release, and perforin/granzyme-mediated cytotoxicity, fludarabine/cyclophosphamide deplete lymphocytes (including Tregs) and reduce cytokine sinks (e.g., IL-7/IL-15), promoting CAR-T expansion/persistence. Targets: Mesothelin-positive solid tumor cells, immune pathways: CAR signaling in T cells, cytotoxic T-cell effector pathways, conditioning targets host lymphocytes.