CARsgen Unveils Promising Results for Satri-cel in Pancreatic Cancer

CARsgen Therapeutics Holdings Limited has presented preliminary results from its Phase Ib clinical trial of satricabtagene autoleucel, known as satri-cel, as an adjuvant therapy for pancreatic cancer. This presentation took place at the European Society for Medical Oncology (ESMO) Congress 2025 in Shanghai on October 20, 2025. The trial, designated CT041-ST-05 (NCT05911217), marks the first proof-of-concept study globally using CAR T-cell therapy in the adjuvant treatment of solid tumors.

Led by Professor Xianjun Yu from Fudan University Shanghai Cancer Center, the trial involved patients with pancreatic ductal adenocarcinoma (PDAC) who had undergone curative surgery. Participants were required to test positive for the Claudin18.2 protein and exhibit elevated carbohydrate antigen 19-9 (CA19-9) levels following adjuvant chemotherapy, indicating a higher risk of recurrence.

The trial enrolled six patients from September 15, 2023, to April 11, 2025. Following their treatment with satri-cel, patients were monitored for a minimum of four weeks. Results revealed that only one patient experienced disease recurrence, while the others remained disease-free, leading to a median follow-up time of 6.05 months. Notably, the nine-month disease-free survival (DFS) rate stood at an impressive 83.3%.

Significant reductions in CA19-9 levels were observed in five patients, with declines ranging from 51.3% to 96.1%. All participants experienced Grade 1 or 2 cytokine release syndrome (CRS) after the initial infusion of satri-cel. In one case, a second infusion led to Grade 3 CRS, which resolved promptly after treatment with tocilizumab. Gastrointestinal disorders, such as nausea and vomiting, were reported but remained manageable.

Dr. Zonghai Li, founder and CEO of CARsgen, expressed optimism regarding these initial findings. He stated, “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.” He emphasized the limited treatment options currently available for high-risk patients following surgical resection.

CARsgen is advancing additional clinical trials for satri-cel, targeting gastric cancer as both an adjuvant therapy and a sequential treatment following first-line therapy. The company aims to broaden curative opportunities for a wider patient population.

About Satri-cel and CARsgen

Satri-cel represents an innovative autologous CAR T-cell therapy aimed at Claudin18.2-positive solid tumors, particularly focusing on gastric and pancreatic cancers. The investigational trials for satri-cel include a confirmatory Phase II clinical trial in China and ongoing studies in North America.

The Chinese National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for satri-cel on June 25, 2025, following its designation for Priority Review and Breakthrough Therapy in earlier months. Additionally, it received Regenerative Medicine Advanced Therapy designation from the U.S. FDA in January 2022.

CARsgen Therapeutics is dedicated to developing innovative CAR T-cell therapies to meet critical clinical needs across various malignancies. The company has established comprehensive capabilities for CAR T-cell research, product development, and large-scale production. Its mission is to provide novel cell therapies globally, making significant strides in the fight against cancer and other serious diseases.