Results of CARsgen's Satri-cel for Adjuvant Treatment for Gastric Cancer Presented at ESMO Congress 2026

SHANGHAI, Oct. 25, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the preliminary positive research results of the investigator-initiated trial (CT041-CG4010, NCT06857786) in China of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product against Claudin18.2), as consolidation therapy following adjuvant treatment for locally advanced gastric or gastroesophageal junction cancer, have been presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2026 (Poster number: 1056P)^[1].

Prognosis remains suboptimal in high-risk patients with locally advanced gastric cancer who have undergone curative gastrectomy, with a 1-year disease-free survival (DFS) rate of only about 73–78%, while the 2-year DFS rate further declines to 58–64%^[2], underscoring the urgent need for novel therapeutic strategies. The CT041-CG4010 trial represents an important attempt worldwide to explore CAR T-cell therapy for post-surgical adjuvant treatment of gastric cancer. This trial enrolled locally advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJC) patients who had undergone radical gastrectomy with D2 lymphadenectomy, with pathologically confirmed (y)pT4aN+ or T4bNany disease. The primary endpoint was safety, and secondary endpoints included efficacy and pharmacokinetics.

According to the study results, up to the data cut-off date (September 14, 2026), 10 patients received satri-cel infusion. All patients had pathological stage T4a or T4b with node-positive disease, of whom up to 80% had N2/N3 stage (60% N3). Lauren diffuse type accounted for 90% of patients and signet-ring cell carcinoma for 70%, collectively indicating a patient population at extremely high risk of postoperative recurrence.

Seven patients had completed at least 12 months of postoperative follow-up, of whom five patients completed M18 post-surgery follow-up, including 2 patients who completed M21 follow-up. None of the infused patients experienced postoperative recurrence or metastasis of gastric cancer; the 12-month (M12) DFS rate was 100% and the median DFS was not reached. One patient was minimal residual disease (MRD)-positive by circulating tumor DNA (ctDNA) before infusion, which turned negative at the first assessment after satri-cel infusion, and remained negative during subsequent follow-up. In terms of pharmacokinetics, all patients showed solid CAR T expansion.

As for safety, the incidence of cytokine release syndrome (CRS) was 80%, and all events were grade 1–2, with a median time to recovery of 4 days. No immune effector cell-associated neurotoxicity syndrome (ICANS) occurred, and no adverse events leading to death were reported. The overall safety profile was manageable.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, stated, "We are pleased to see that satri-cel has shown encouraging preliminary results in the novel exploratory setting of adjuvant therapy following gastrectomy. For patients with locally advanced gastric cancer at high risk of postoperative recurrence, the benefit of existing adjuvant therapies remains limited. In this study, none of the patients have experienced recurrence to date, the 12-month DFS rate reached 100%, and one patient's MRD converted from positive to negative. These findings suggest that satri-cel may clear minimal residual disease and potentially alter the disease course for these patients, with a more favorable safety profile than in the later-line setting and overall manageable. Building on the approval of satri-cel for later-line treatment of advanced gastric cancer, we will continue to advance its exploration into earlier-line settings such as post-surgical adjuvant therapy and sequential therapy following first-line treatment, with the goal of providing better curative opportunities for a broader patient population."

About Satri-cel
Satri-cel is an autologous CAR T-cell therapy product against the protein Claudin18.2 that is the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors. It was approved by the NMPA in June 2026 for the treatment of Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy, making it the world's first approved CAR T-cell therapy product for solid tumors.

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 pancreatic cancer adjuvant therapy in China (NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (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

SOURCE CARsgen Therapeutics