CARsgen Therapeutics Holdings Limited (stock code: 2171) released findings from its Phase Ib clinical trial of satricabtagene autoleucel (satri-cel) for pancreatic cancer adjuvant therapy. According to the announcement, the trial (CT041-ST-05, NCT05911217) was presented as a poster on October 19, 2025, at the European Society for Medical Oncology (ESMO) Congress 2025 in Madrid.
Satri-cel is an autologous chimeric antigen receptor (CAR) T-cell product candidate targeting the Claudin18.2 protein found in certain solid tumors, including gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer. Ongoing clinical studies include a confirmatory Phase II trial in China for advanced G/GEJA (CT041-ST-01), a Phase Ib investigational study for pancreatic cancer adjuvant therapy (CT041-ST-05), additional investigator-initiated trials in China, and a Phase 1b/2 trial in North America (CT041-ST-02). The Group noted that the Center for Drug Evaluation of the National Medical Products Administration in China has accepted the New Drug Application for satri-cel in advanced G/GEJA, and that it has received multiple regulatory designations, including Priority Review and Breakthrough Therapy in China, as well as Regenerative Medicine Advanced Therapy designation in the United States.
The announcement emphasizes that further information regarding these data will be available on the company’s website. It also highlights the associated risks and uncertainties common to clinical development, noting there is no guarantee of successful commercialization of satri-cel. The company advises shareholders and potential investors to exercise caution when dealing in its shares, in line with stock exchange requirements and its forward-looking statements disclaimer.