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ShanghaiJune 1, 2026 /PRNewswire/ — CARsgen Therapeutics (Stock Code: 2171.HK), a biopharmaceutical company focused on developing innovative CAR-T cell therapies, announced that the long-term analysis results of satricabtagene autoleucel (Product Code: CT041, an autologous CAR-T cell therapy candidate targeting the Claudin18.2 protein) as sequential therapy after first-line treatment in patients with advanced gastric cancer/gastroesophageal junction adenocarcinoma (G/GEJA) were presented as a poster at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, held from 13:30 to 16:30 Central Daylight Time on May 30, 2026. The presentation was titled “Long-term Follow-up of Satricabtagene autoleucel (satri-cel) as Sequential Therapy After First-Line Treatment for Advanced Gastric Cancer – a subgroup analysis”[1].
In this cohort, a total of 5 patients with Claudin18.2-positive gastric/gastroesophageal junction cancer received an infusion of satricabtagene autoleucel at a dose of 2.50×10⁸ cells after first-line treatment. Regarding disease characteristics, 3 patients (60%) had Lauren diffuse type, 1 (20%) had mixed type, 4 (80%) had signet ring cell carcinoma, and 4 (80%) had peritoneal metastasis, features typically associated with extremely poor survival prognosis. The median number of first-line treatment cycles among the 5 patients was 5 cycles (range: 4-11), and only 1 patient achieved a partial response (PR) to first-line treatment, indicating overall suboptimal efficacy.
As of October 18, 2025, the median follow-up time from the start of first-line treatment for the 5 patients was 54.6 months. Among the 4 patients with target lesions, the confirmed objective response rate (ORR) after satricabtagene autoleucel treatment was 100%, with the median duration of response (DOR) not yet reached; the other patient without target lesions maintained stable disease for 20.9 months. The median progression-free survival (PFS) from the start of first-line treatment for the 5 patients reached 20.9 months. Among them, 2 patients experienced significant clinical benefit after satricabtagene autoleucel treatment and had the opportunity to undergo surgical resection, remaining alive as of the data cutoff date, with follow-up times of 58.1 months and 51.1 months, respectively.
In terms of safety, no grade 3 or higher cytokine release syndrome (CRS) occurred, no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed, and there were no treatment-related deaths. No grade ≥3 infections or febrile neutropenia occurred.
In summary, over a long-term follow-up of more than 4.5 years, satricabtagene autoleucel as first-line sequential therapy demonstrated durable survival benefits and a manageable safety profile in patients with advanced gastric/gastroesophageal junction cancer, highlighting its significant potential and clinical value in the frontline treatment of gastric cancer.
About Satricabtagene autoleucel
Satricabtagene autoleucel is a potentially global first-in-class, autologous CAR-T cell therapy candidate targeting the Claudin18.2 protein, intended for the treatment of Claudin18.2-positive solid tumors, primarily gastric/gastroesophageal junction adenocarcinoma and pancreatic cancer.
On June 25, 2025, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for satricabtagene autoleucel for the treatment of patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. In May 2025, satricabtagene autoleucel was granted priority review by the CDE. In March 2025, satricabtagene autoleucel received Breakthrough Therapy Designation from the CDE.
About CARsgen Therapeutics
CARsgen Therapeutics (Stock Code: 2171.HK) is a biopharmaceutical company focused on developing innovative CAR-T cell therapies to address unmet clinical needs, including but not limited to hematological malignancies, solid tumors, and autoimmune diseases. The company has established end-to-end capabilities for CAR-T cell research and development, from target discovery, preclinical research, and product clinical development to commercial-scale production. Through proprietary technologies and a product pipeline with global rights, the company aims to address challenges in existing CAR-T cell therapies, such as improving safety, enhancing efficacy in solid tumor treatment, and reducing treatment costs. CARsgen’s mission is to become a global leader in the biopharmaceutical field, providing innovative and differentiated cell therapies for patients with cancer and other diseases worldwide, making cancer and other diseases curable.
Forward-Looking Statements
All statements in this press release that are not historical facts or related to current facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs, and expectations regarding future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. Therefore, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements, and the forward-looking events discussed in this press release may not occur. These risks and uncertainties include, but are not limited to, those detailed under the heading “Key Risks and Uncertainties” in our most recent annual report and interim report, as well as other announcements and reports published on our company website at https://www.carsgen.com. We make no representation or warranty as to the achievement or reasonableness of any projections, targets, estimates, or forecasts in this press release, and reliance should not be placed on them.
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