An Open-label, Single-arm, Phase I Clinical Trial to Evaluate the Safety and Efficacy of TX103 CAR-T Cells in Participants With Advanced Solid Tumors

TX103 CAR-T cells are autologous T cells genetically engineered to express a chimeric antigen receptor (CAR) targeting TX103-positive tumor cells. This therapy is designed to recognize and kill TX103-expressing malignant cells. TX103 CAR-T cells are administered either via intravenous (IV) infusion or intraperitoneal (IP) infusion, depending on the cohort. For dose-escalation cohorts (Phase Ia), a standard 3+3 design is used: 1. IV dose-escalation cohort: planned doses range from 1.0 × 10⁸ to 2.0 × 10⁹ CAR-T cells. 2. IP dose-escalation cohort: initiated sequentially after the IV cohort; starting dose is based on the safe and potentially efficacious dose from IV cohort, with planned escalation up to 4.0 × 10⁹ CAR-T cells. The Phase Ib expansion cohort administers TX103 CAR-T at the dose determined to be safe and potentially efficacious in Phase Ia, focusing on tumor types that showed preliminary signs of antitumor activity and meet clinical needs. TX103 CAR-T therapy is distinct fro