CARsgen Therapeutics Holdings Limited (HK:2171), a Chinese developer of innovative CAR T-cell therapies, announced on Sunday that research results of the Phase Ib registrational clinical trial of satricabtagene autoleucel (satri-cel, CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for pancreatic cancer (PC) adjuvant therapy in China have been presented in poster session at European Society for Medical Oncology (ESMO) Congress 2025.

The poster was titled 'Adjuvant Therapy with Claudin18.2-specific CAR T Cells (Satri-cel) in High-Risk Pancreatic Cancer (CT041-ST-05)'. This trial represents the world's first proof-of-concept study exploring CAR T-cell therapy for the adjuvant treatment of solid tumors. Professor Xianjun Yu from Fudan University Shanghai Cancer Center serves as the principal investigator.

Elevated carbohydrate antigen 19-9 (CA19-9) levels post resection indicate aggressive tumor biology and higher risk of recurrence. The median interval is approximately 3 months between CA19-9 elevation and radiological recurrence. Current standard adjuvant therapies have limited effectiveness for high-risk patients, highlighting the urgent need for novel strategies.

This trial enrolled patients with Claudin18.2 positive PDAC who have undergone curative-intent resection, with abnormal CA19-9 after 3 months adjuvant chemotherapy and no evidence of recurrence. From September 2023 to April 2025, six patients received satri-cel infusion and completed at least 4 weeks of follow-up.

With a median follow-up of 6.05 months from infusion, only one patient experienced disease recurrence. The median disease-free survival (DFS) and median overall survival (OS) were not reached. The 9-month DFS rate from surgery was 83.3%. Notably, one patient who has completed 52-week follow-up post infusion is still under follow-up without disease recurrence. Moreover, significant decline in CA19-9 levels post infusion was observed in five (83.3%) patients, with reductions ranging from 51.3% to 96.1%.

All patients developed Grade 1 or 2 cytokine release syndrome (CRS) after the first satri-cel infusion. For the second infusion administered in one patient, grade 3 CRS accompanied by hypotension was observed, which was resolved within three days following tocilizumab treatment. All patients experienced gastrointestinal disorders, such as nausea and vomiting, which were all Grade 1 or 2. Only one case of Grade 3 gastritis occurred. No immune effector cell-associated neurotoxicity syndrome was reported.

Dr. Zonghai Li, CARsgen Therapeutics founder, chairman of the board, chief executive officer, and chief scientific officer, commented: "We are pleased to see that satri-cel has shown promising preliminary efficacy with a manageable safety profile in the highly challenging setting of pancreatic cancer adjuvant therapy. For patients at high risk of recurrence after surgical resection of pancreatic cancer, there are currently very few effective treatment options. In this trial, the sustained disease-free survival and marked declines in CA19-9 levels suggest that satri-cel, an innovative cellular immunotherapy, may clear minimal residual disease and potentially alter the disease course for these patients. Furthermore, we are actively advancing clinical trials exploring satri-cel for gastric cancer adjuvant therapy and as a sequential treatment following first-line gastric cancer therapy, with the goal of providing better curative opportunities for a broader patient population."