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CARsgen Therapeutics Announces Positive Phase II Results for Satricabtagene Autoleucel in Gastric Cancer

NextEdge Admin

02 Jan 2025

2 min 25 sec

CARsgen Therapeutics Holdings Limited (2171.HK), a leader in innovative CAR T-cell therapies for hematologic malignancies and solid tumors, announced positive results from the pivotal Phase II trial (CT041-ST-01, NCT04581473) for satricabtagene autoleucel ("satri-cel"), an autologous CAR T-cell therapy targeting Claudin18.2. This open-label, multicenter trial evaluated satri-cel in patients with advanced gastric/gastroesophageal junction (GC/GEJ) cancers expressing Claudin18.2, who had failed at least two prior therapies.

Patients were randomized 2:1 to receive satri-cel infusion or physician’s choice of treatment (e.g., paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). The study achieved its primary endpoint, demonstrating statistically significant improvement in progression-free survival (PFS) as assessed by the Independent Review Committee. The safety profile of satri-cel was manageable, consistent with prior studies.

Dr. Zonghai Li, Founder and CEO of CARsgen, hailed the results as a milestone for CAR-T therapy in solid tumors, expressing plans to submit a New Drug Application (NDA) to China’s NMPA in 2025. If approved, satri-cel could become the world’s first CAR-T therapy for solid tumors. CARsgen is also investigating satri-cel in adjuvant settings for gastric and pancreatic cancers.

Satri-cel, targeting Claudin18.2, is positioned to be a first-in-class therapy for Claudin18.2-positive GC/GEJ and pancreatic cancer. It has received RMAT and Orphan Drug designations from the U.S. FDA.

CARsgen combines innovative CAR-T research, clinical trials, and large-scale manufacturing to address challenges in CAR-T therapies, including safety, efficacy in solid tumors, and cost. The company is dedicated to advancing transformative therapies, aiming to make cancer curable globally.