CARsgen Therapeutics Holdings Limited has presented groundbreaking preliminary results from the world's first proof-of-concept study exploring CAR T-cell therapy for adjuvant treatment of solid tumors. The Phase Ib registrational clinical trial of satricabtagene autoleucel (satri-cel, CT041) for pancreatic cancer adjuvant therapy was presented at the European Society for Medical Oncology (ESMO) Congress 2025.
The trial, designated CT041-ST-05 (NCT05911217), represents a significant milestone in cellular immunotherapy, marking the first time CAR T-cell therapy has been investigated in the adjuvant setting for solid tumors. Professor Xianjun Yu from Fudan University Shanghai Cancer Center serves as the principal investigator for this pioneering study.
Addressing Critical Unmet Need in Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC) is characterized by a dismal prognosis even among patients who undergo surgical resection. Local recurrence and distant metastasis are common, often leading to treatment failure. Elevated carbohydrate antigen 19-9 (CA19-9) levels post resection indicate aggressive tumor biology and higher risk of recurrence, with the median interval being 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. The trial specifically enrolled patients with Claudin18.2 positive PDAC who had undergone curative-intent resection, with abnormal CA19-9 after 3 months adjuvant chemotherapy and no evidence of recurrence.
Encouraging Efficacy Results
From September 15, 2023 to April 11, 2025 (data cut-off date), 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, while others remain disease-free.
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 continues under follow-up without disease recurrence.
A particularly encouraging finding was the significant decline in CA19-9 levels post infusion observed in five (83.3%) patients, with reductions ranging from 51.3% to 96.1%. This biomarker response suggests potential clearance of minimal residual disease.
Manageable Safety Profile
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. Importantly, no immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.
Clinical Significance and Future Directions
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, commented on the results: "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."
He added, "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."
Expanding Clinical Development Program
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. The therapy targets Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer.
CARsgen is actively advancing clinical trials exploring satri-cel for gastric cancer adjuvant therapy and as a sequential treatment following first-line gastric cancer therapy. The company's broader clinical program includes multiple ongoing trials across different indications and treatment settings.
Regulatory Recognition
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. The therapy has been granted Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025 by the CDE.
Additionally, satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022, and received Orphan Drug designation from the U.S. FDA for the treatment of G/GEJA in September 2020.
