SHANGHAI , Aug. 19, 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 that the completion of enrollment in the pivotal Phase II clinical trial of satricabtagene autoleucel ("satri-cel", R&D code: CT041, an autologous CAR-T product candidate against Claudin18.
2) in accordance with the clinical protocol, for advanced gastric/gastroesophageal junction cancers (GC/GEJ) in China . This study is an open-label, multicenter, randomized clinical trial in China evaluating the efficacy and safety of satri-cel in subjects with Claudin18.2-positive advanced GC/GEJ patients who have failed at least two prior lines of therapy.
Treatment for the control group is physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Gastric cancer is one of the most common malignant tumors in China , with an incidence of approximately 359,000 incident cases and a mortality of approximately 260,000 deaths in 2022 [1] . Patients with advanced gastric cancer often face limited treatment options and poor prognosis.
There is a strong need for more innovative and efficacious therapies. Satri-cel is an autologous CAR T-cell product candidate against Claudin18.2 that has the potential to be first-in-class globally.
It primarily targets GC/GEJ and pancreatic cancer (PC). The published clinical data on satri-cel have shown promising safe.