CARsgen Unveils Promising Pancreatic Cancer Therapy Results

CARsgen Therapeutics Holdings Limited has presented preliminary results from its Phase Ib clinical trial of satricabtagene autoleucel, known as “satri-cel,” at the European Society for Medical Oncology (ESMO) Congress 2025. The trial, which focuses on adjuvant therapy for pancreatic cancer, marks a significant step in the exploration of CAR T-cell therapies for solid tumors.

The study, identified as CT041-ST-05 and registered under NCT05911217, was led by Professor Xianjun Yu from Fudan University Shanghai Cancer Center. It is notable for being the first proof-of-concept trial to investigate CAR T-cell therapy in the context of adjuvant treatment for pancreatic ductal adenocarcinoma (PDAC), a condition known for its poor prognosis, particularly after surgical resection.

Pancreatic cancer often leads to local recurrence and distant metastasis, complicating treatment outcomes. Following surgical removal, elevated levels of carbohydrate antigen 19-9 (CA19-9) are associated with aggressive tumor behavior and a heightened risk of recurrence. Historically, the median time between an increase in CA19-9 and radiological recurrence is about three months.

The trial involved patients with Claudin18.2 positive PDAC who had undergone curative-intent surgery but exhibited abnormal CA19-9 levels three months after receiving adjuvant chemotherapy. Between September 15, 2023, and April 11, 2025, six patients received satri-cel infusion and completed a minimum follow-up of four weeks.

Results indicated that, with a median follow-up of 6.05 months post-infusion, just one patient experienced disease recurrence, while the remaining participants remain disease-free. The median disease-free survival (DFS) and median overall survival (OS) have yet to be reached. Impressively, the nine-month DFS rate following surgery stands at 83.3%. One patient, who has completed a 52-week follow-up, shows no signs of disease recurrence.

Significant declines in CA19-9 levels were observed in five of the six patients (83.3%), with reductions ranging from 51.3% to 96.1% following treatment. All participants experienced Grade 1 or 2 cytokine release syndrome (CRS) after the initial satri-cel infusion. One patient who received a second infusion developed Grade 3 CRS, which included hypotension but was resolved within three days following treatment with tocilizumab. Gastrointestinal disorders, such as nausea and vomiting, were reported as Grade 1 or 2, with only one case of Grade 3 gastritis noted. Importantly, no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

Dr. Zonghai Li, Founder, Chairman, CEO, and Chief Scientific Officer of CARsgen Therapeutics, expressed optimism regarding the trial results, stating, “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 highlighted the limited treatment options available for patients at high risk of recurrence following surgical resection. The sustained disease-free survival and significant declines in CA19-9 levels suggest that satri-cel may effectively target minimal residual disease and alter the disease trajectory for these patients.

In addition to its focus on pancreatic cancer, CARsgen is actively pursuing clinical trials for satri-cel in gastric cancer adjuvant therapy and as a follow-up treatment after first-line therapy for gastric cancer, aiming to expand treatment options for a wider patient population.

About Satri-cel and CARsgen Therapeutics

Satri-cel is an autologous CAR T-cell product candidate targeting the Claudin18.2 protein and could potentially become a first-in-class therapy. It aims to treat Claudin18.2-positive solid tumors, with a primary focus on gastric and gastroesophageal junction adenocarcinomas as well as pancreatic cancer.

Current trials include a range of studies assessing the efficacy of satri-cel for various cancer types, including advanced gastric cancer. On June 25, 2025, the Center for Drug Evaluation (CDE) of China accepted the New Drug Application (NDA) for satri-cel in the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma, following positive designations from the CDE and the U.S. FDA.

CARsgen Therapeutics is dedicated to developing innovative CAR T-cell therapies to meet unmet clinical needs across hematologic malignancies, solid tumors, and autoimmune diseases. The company has established comprehensive capabilities for CAR T-cell research and development, emphasizing improving safety, enhancing efficacy, and reducing treatment costs to provide effective therapies for patients worldwide.