CARsgen reports positive satri-cel data for pancreatic cancer adjuvant therapy

CARsgen Therapeutics Holdings Limited announced the presentation of research results from its Phase Ib clinical trial of satri-cel at the European Society for Medical Oncology (ESMO) Congress 2025. The poster presentation, titled "Adjuvant Therapy with Claudin18.2-specific CAR T Cells (Satri-cel) in High-Risk Pancreatic Cancer (CT041-ST-05),” occurred on October 19, 2025. Satri-cel is an autologous CAR T-cell product candidate designed to target the Claudin18.2 protein, with potential as a first-in-class treatment.

The company is developing satri-cel for Claudin18.2-positive solid tumors, specifically focusing on gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials, a confirmatory Phase II trial for advanced G/GEJA in China, and a Phase Ib registrational trial for PC adjuvant therapy in China, among others.

Earlier this year, China's NMPA Center for Drug Evaluation (CDE) accepted the New Drug Application (NDA) for satri-cel for advanced G/GEJA, granting it Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025. Additionally, the U.S. FDA granted satri-cel Regenerative Medicine Advanced Therapy (RMAT) designation in January 2022 and Orphan Drug designation in September 2020 for advanced G/GEJA.