eligibility_summary
Adults 18–75, BMI ≥18.5, ECOG ≤2, ≥12‑wk survival, advanced GI/other solid tumors after standard therapy failure/intolerance, measurable disease (RECIST 1.1), adequate organs (LVEF ≥50%, SpO2 >93%), TM4SF1+ by IHC, negative pregnancy. Exclude: immunotherapy allergy, unresolved ≥G2 AEs, serious autoimmune on immunosuppression, unstable systemic disease, CNS mets, active bleeding/thrombosis, uncontrolled effusions, high‑dose steroids, other active cancer ≤5 y, active HBV/HCV, HIV, syphilis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous, gene‑modified chimeric antigen receptor T‑cell (CAR‑T) therapy targeting TM4SF1 (biologic/cellular immunotherapy). CAR construct includes an EGFR‑based safety switch. Mechanism of action: Patient T cells are engineered ex vivo to express a CAR that binds TM4SF1 on tumor cells, triggering T‑cell activation (signal transduction via CAR domains), cytokine release, and cytotoxic killing of TM4SF1‑expressing cells, cells can be eliminated via the EGFR safety switch if needed. Targets: TM4SF1 (Transmembrane 4 L Six Family Member 1), a cell‑surface tetraspanin‑like protein highly expressed in digestive system cancers (pancreatic, colorectal, gastric, liver), implicated in cell development, activation, growth, motility, invasion/metastasis. Delivery: IV or local infusion with dose escalation (0.5–10×10^6 cells/kg).