CARsgen Therapeutics announced positive topline results from its pivotal Phase II clinical trial (CT041-ST-01) of satricabtagene autoleucel (satri-cel, CT041) for patients with Claudin18.2 expression-positive, advanced gastric and gastroesophageal junction (GC/GEJ) cancers. The open-label, multicenter trial, conducted in China, demonstrated a statistically significant improvement in progression-free survival (PFS) compared to physician's choice of therapy.
Trial Design and Results
The Phase II trial randomized patients 2:1 to receive either satri-cel infusion or physician's choice of treatment, which included options such as paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab. The primary endpoint was PFS, assessed by an Independent Review Committee (IRC). The study met its primary endpoint, showing a statistically significant improvement in PFS for patients treated with satri-cel compared to those receiving physician's choice. Previous data indicated a manageable safety profile for satri-cel.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, stated, "The study demonstrates that satri-cel provides significant benefits to gastric cancer patients who have failed at least two prior lines of therapy. This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors."
Regulatory and Development Plans
CARsgen anticipates submitting a New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China in the first half of 2025. If approved, satri-cel could become the world's first CAR-T product for solid tumors. The company also plans to explore satri-cel's potential in adjuvant therapy for gastric and pancreatic cancers.
In March 2025, China's NMPA granted Breakthrough Therapy Designation (BTD) to satri-cel for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy. The U.S. FDA has also granted Regenerative Medicine Advanced Therapy (RMAT) designation to satri-cel for advanced GC/GEJ with Claudin18.2-positive tumors in January 2022, and Orphan Drug designation in 2020 for the same indication.
About Satri-cel
Satri-cel is an autologous CAR T-cell product candidate targeting the Claudin18.2 protein, which is overexpressed in gastric, gastroesophageal junction, and pancreatic cancers. It is designed to target and destroy tumor cells expressing Claudin18.2. Ongoing trials include a Phase I clinical trial for pancreatic cancer adjuvant therapy in China (CT041-ST-05, NCT05911217) and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).
CARsgen's Broader Pipeline
CARsgen Therapeutics is a biopharmaceutical company focused on developing innovative CAR T-cell therapies for hematologic malignancies and solid tumors. The company has established a comprehensive CAR T-cell research and development platform covering target discovery, CAR T-cell development, clinical trials, and commercial-scale production.
