CARsgen Announces Positive Topline Results from China GC/GEJ Pivotal Phase II Clinical Trial of Claudin18.2 CAR-T (Satri-cel)

SHANGHAI, Dec. 30, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the positive results from the pivotal Phase II clinical trial CT041-ST-01(NCT04581473). This study is an open-label, multicenter clinical trial evaluating the safety and efficacy of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) in subjects with Claudin18.2 expression-positive, advanced gastric/gastroesophageal junction cancers that have failed at least 2 prior lines therapy. Patients were 2:1 randomly assigned to receive treatment of satricabtagene autoleucel infusion or treatment of physician's choice (including paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). The primary endpoint of the trial is progression-free survival (PFS) assessed by the Independent Review Committee (IRC). The study met its primary endpoint of a statistically significant improvement in PFS assessed by IRC for patients treated with satri-cel infusion as compared to treatment of physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Previous data demonstrates that the safety profile of satricabtagene autoleucel was manageable.

"We are thrilled to see that satri-cel has achieved positive results in the pivotal Phase II clinical trial in China. 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. We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world's first CAR-T product for solid tumors, bringing hope to more patients as soon as possible. Additionally, we will continue to explore the potential of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.