CARsgen Therapeutics Holdings Limited , 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 safety and efficacy.

The final results of the investigator-initiated Phase I clinical trial CT041-CG4006 (NCT03874897) were published in Nature Medicine and orally presented at the 2024 ASCO annual meeting. There were no dose-limiting toxicities (DLTs), no Grade 3 or higher cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) observed. In 51 patients with GC/GEJ with target lesions at baseline who received satri-cel monotherapy, the overall response rate (ORR) was 54.9% (28/51), the disease control rate (DCR) was 96.1% (49/51), and the median duration of response (mDOR) was 6.4 months.^[2][3] The phase Ib results from CT041-ST-01 (NCT04581473) clinical trial presented at the 2022 ASCO annual meeting, further showed the manageable safety and promising efficacy of satri-cel. Among 14 GC/GEJ patients who had received at least 2 prior lines of treatment and received satri-cel monotherapy, there were no DLTs or AEs leading to death. No ICANS or gastrointestinal mucosal injury were reported. The ORR and DCR were 57.1% and 78.6% respectively.^[4]

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are very pleased to announce the successful completion of patient enrollment in the pivotal Phase II clinical trial of satri-cel in China. This significant milestone marks another solid step forward in our development of CAR T-cell therapies for solid tumors. We extend our gratitude to all the investigators, the patients and their families for their trust and support. We look forward to the submission of New Drug Application and the approval in China, to benefit patients with gastric cancer. As one of the leading companies in the field of CAR T-cell therapies, we remain committed to addressing the major challenges faced by existing CAR T-cell therapies and will develop more innovative CAR-T products for cancer patients."