CARsgen Reveals Promising Results for Satri-cel in Pancreatic Cancer

CARsgen Therapeutics Holdings Limited has presented preliminary findings from its Phase Ib clinical trial of satricabtagene autoleucel, commonly referred to as **satri-cel**, for the treatment of pancreatic cancer. The results were shared during a poster session at the **European Society for Medical Oncology (ESMO) Congress 2025** in Shanghai on **October 20, 2025**. This research marks a significant milestone as it represents the first proof-of-concept study of CAR T-cell therapy targeting solid tumors in an adjuvant setting.

The trial, identified as **CT041-ST-05** (NCT05911217), focused on patients with pancreatic ductal adenocarcinoma (PDAC) who had undergone surgical resection. These patients had elevated levels of carbohydrate antigen 19-9 (CA19-9) post-surgery, indicating an aggressive tumor biology and a higher likelihood of recurrence. Current standard therapies are limited in effectiveness, underscoring the demand for innovative treatment options.

The study enrolled patients with **Claudin18.2** positive PDAC who had received adjuvant chemotherapy. From **September 15, 2023**, to **April 11, 2025**, six patients were treated with satri-cel and followed for a minimum of four weeks. With a median follow-up of **6.05 months**, only one patient experienced disease recurrence, while the remaining participants remained disease-free. The **9-month disease-free survival (DFS)** rate was calculated at **83.3%**, with the median DFS and overall survival (OS) yet to be determined.

Among the observed effects, five patients (or **83.3%**) demonstrated significant declines in CA19-9 levels post-infusion, with reductions varying from **51.3% to 96.1%**. All participants experienced mild to moderate symptoms of cytokine release syndrome (CRS) after the initial infusion, while one patient experienced grade 3 CRS associated with hypotension following a second infusion. This condition was effectively managed with tocilizumab treatment.

Dr. Zonghai Li, Founder, Chairman of the Board, and CEO of CARsgen Therapeutics, expressed optimism regarding 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 stated.

He further highlighted that the sustained disease-free survival and significant declines in CA19-9 levels suggest that satri-cel could potentially clear minimal residual disease and change the course of treatment for these patients. CARsgen is also pursuing clinical trials for satri-cel in gastric cancer adjuvant therapy, aiming to broaden treatment options.

About Satri-cel and CARsgen Therapeutics

Satri-cel is an innovative autologous CAR T-cell product candidate targeting Claudin18.2, specifically designed for treating solid tumors, with a primary focus on gastric and gastroesophageal junction adenocarcinoma as well as pancreatic cancer. The company has initiated several trials, including a confirmatory Phase II clinical trial for advanced gastric/gastroesophageal junction adenocarcinoma in China, among others.

The **Center for Drug Evaluation (CDE)** of China’s National Medical Products Administration has accepted a New Drug Application for satri-cel, which received Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025. In the United States, satri-cel has also received Regenerative Medicine Advanced Therapy designation from the FDA for treating advanced Claudin18.2-positive tumors.

CARsgen Therapeutics is dedicated to advancing CAR T-cell therapies to address critical clinical needs, including those related to hematologic malignancies and solid tumors. The company aims to innovate within the field, enhancing safety and efficacy while reducing costs associated with treatment.

As the landscape of cancer treatment continues to evolve, CARsgen’s developments with satri-cel present a notable advancement, offering hope for improved outcomes for patients facing the challenges of pancreatic cancer and other difficult-to-treat malignancies.