eligibility_summary
Adults ≥18 with CLDN18.2+ unresectable/metastatic solid tumors. Phase 1: select GI/ovarian/NSCLC, Phase 2: gastric/GEJ/esophageal, PDAC, ovarian/NSCLC. ≥2 prior lines (PDAC ≥1, Phase 2 max 4). Measurable disease, ECOG 0–1, ≥12‑wk life expectancy, adequate organs/vascular, SOC targeted therapies tried/declined, contraception, controlled HBV/HCV. Exclude prior adoptive/gene therapy (Phase 2 prior CLDN18.2), active CNS/autoimmune/infections, recent therapy/vaccines, major cardiac/pulmonary/GI issues, transplant, other active cancers, pregnancy/noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: TAC01-CLDN18.2, an autologous gene‑modified T‑cell therapy (cellular immunotherapy). Patient T cells are engineered to express a T‑cell Antigen Coupler (TAC) that binds Claudin 18.2 (CLDN18.2) on tumors and, upon engagement, activates the cells via the native T‑cell receptor (TCR) signaling machinery, driving T‑cell activation, expansion, and cytotoxic killing. Given as a single IV infusion after lymphodepletion with fludarabine or clofarabine (purine analogs), cyclophosphamide (alkylating agent), and nab‑paclitaxel (microtubule inhibitor) to enhance engraftment. Target cells/pathways: CLDN18.2‑expressing solid tumor cells (e.g., gastric/GEJ/esophageal adenocarcinoma, PDAC, mucinous ovarian cancer, NSCLC). Key pathways: antigen recognition of CLDN18.2 and activation through endogenous TCR/CD3 signaling in autologous T cells.