SHANGHAI, May 31, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the long-term analysis results of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2), as sequential therapy after first-line (1L) treatment in patients with advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA), have been presented as a poster presentation at the 2026 ASCO Annual Meeting on May 30, 2026, 13:30 – 16:30, CDT. The poster 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].

The investigator-initiated trial of satri-cel, CT041-CG4006 (NCT03874897), is an open-label, multi-cohort, phase 1 study designed to evaluate the safety and efficacy of satri-cel in patients with Claudin18.2-positive advanced gastrointestinal cancers. Results from all cohorts were published in Nature Medicine and presented at the ASCO Annual Meeting in 2024^{[2] [3]}. The 2026 ASCO Annual Meeting features the long-term follow-up results of Cohort 3 from this study, with a follow-up duration exceeding 4.5 years.

In this cohort, 5 patients with Claudin18.2-positive gastric/gastroesophageal junction (G/GEJ) cancer received satri-cel infusion at a dose of 2.50×10⁸ cells sequentially after 1L therapy. Three patients (60%) had Lauren diffuse type, 1 (20%) had mixed type, 4 (80%) had signet ring cell carcinoma, and 4 (80%) had peritoneal metastases. These characteristics are generally associated with extremely poor survival prognosis. Five patients had received a median of 5 cycles (range, 4-11) of 1L chemotherapy before satri-cel infusion, with only 1 patient achieved partial response (PR) after 1L therapy. Overall, the efficacy of 1L therapy was poor.

As of October 18, 2025, the median follow-up of the 5 patients from initial 1L therapy was 54.6 months. Among the 4 patients with target lesions, the confirmed objective response rate (ORR) was 100%, and the median duration of response (DOR) was not reached. The one patient without target lesions maintained stable for 20.9 months. Among the 5 patients, the median progression-free survival (PFS) since 1L therapy was 20.9 months. Among these, 2 patients, with significant clinical benefit, underwent surgical resection after satri-cel therapy. As of the data cutoff date, both patients remained alive, with follow-up durations of 58.1 months and 51.1 months.

As for safety, no grade 3 or higher cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, and no treatment-related deaths occurred. No grade ≥3 infections or febrile neutropenia were reported.

With a long-term follow-up exceeding 4.5 years, satri-cel as 1L sequential treatment continues to demonstrate durable survival benefit with a manageable safety profile in patients with advanced G/GEJ cancer, supporting its highly promising potential and clinical value in earlier lines of therapy.

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer (PC).

The Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satri-cel for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy on June 25, 2025. It has been granted Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025 by the CDE.

The Company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer: including an ongoing Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (CT041-CG4011, NCT07179484).

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to 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. As a result, 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 might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

References

[1] Qi C, et al. ASCO 2026. 2026 Jun; Poster #2557
[2] Qi C, et al. Nat Med (2024). DOI: 10.1038/s41591-024-03037-z2
[3] Qi C, et al. ASCO 2024. 2024 Jun; Oral presentation #2501

For more information, please visit https://www.carsgen.com/

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