CARsgen’s CAR-T Satri-Cel Significantly Reduces CA19-9 Levels in Patients With Pancreatic Ductal Adenocarcinoma

In a phase 1b clinical trial (CT041-ST-05, NCT05911217) for pancreatic ductal adenocarcinoma (PDAC), 5 of 6 patients (83.3%) treated with CARsgen’s Claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) satricabtagene autoleucel (satri-cel) as an adjuvant therapy showed significant posttreatment decreases in carbohydrate antigen 19-9 (CA19-9).¹ The data were presented in a poster at the European Society for Medical Oncology (ESMO) Congress 2025, which took place October 17 to 21, in Berlin, Germany.

CARsgen pointed out that CA19-9 at elevated levels following surgical resection suggests a higher risk of tumor recurrence, along with an aggressive tumor biology, and a median interval of approximately 3 months has been observed from elevation of CA19-9 to radiological recurrence. All treated patients in the phase 1b trial had previously received curative-intent resection and following 3 months of adjuvant chemotherapy showed abnormal CA19-9, without indication of disease recurrence.

All patients had 4 weeks or more of follow-up after treatment with satri-cel (median follow-up, 6.05 months). It was noted that the CA19-9 reductions in the 5 patients observed after infusion of satri-cel ranged from 51.3% to 96.1%. Furthermore, disease recurrence was seen in only 1 of the 6 treated patients as of the latest follow-up. Carsgen stated that the median disease-free survival (DFS) and median overall survival were not reached and that an 83.3% DFS rate was observed at 9 months from surgery. The company highlighted a patient who reached 52 weeks of postinfusion follow-up without disease recurrence and is continuing to undergo follow-up.

With regard to safety, grade 1 to 2 gastrointestinal disorders (e.g. nausea and vomiting) were recorded in all 6 treated patients. A grade 3 case of gastritis was reported in 1 patient. There were no cases of immune effector cell-associated neurotoxicity syndrome in any patients. Notably, 1 of the 6 patients received a second infusion of satri-cel, whereas all other patients received only 1 infusion of the CAR-T. After the first satri-cel infusion, all patients experienced cases of cytokine release syndrome (CRS) graded as 1 to 2 in severity. A grade 3 case of CRS, which included hypotension, occurred in the 1 patient who received a second infusion of satri-cel after that infusion. The adverse event was resolved within 3 days of administration of tocilizumab.

“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,” Zonghai Li, MD, PhD, the founder, chairman of the board, CEO, and chief scientific officer of CARsgen, said in a statement.¹ “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.”

Notably, a new drug application (NDA) for satri-cel for gastric/gastroesophageal junction adenocarcinoma (G/GEJA) is currently under review by China's National Medical Products Administration (NMPA).² The NDA is supported primarily by data from the phase 2 CT041-ST-01 randomized controlled clinical trial (NCT04581473), which is being carried out in China. Notably, the company received priority review for satri-cel from the NMPA in May 2025 for the indication covered in the NDA and previously had received breakthrough therapy designation from the NMPA for it in March 2025.^3,4

REFERENCES
1. CARsgen presents preliminary results on satri-cel for adjuvant therapy of pancreatic cancer at ESMO Congress 2025. News release. CARsgen Therapeutics Holdings Limited. October 20, 2025. Accessed October 23, 2025. https://www.carsgen.com/en/news/20251020/
2. Carsgen Therapeutics announces NDA acceptance of satri-cel by China’s NMPA. News release. CARsgen Therapeutics Holdings Limited. June 26, 2025. Accessed July 7, 2025. https://www.carsgen.com/en/news/20250626/
3. Carsgen’s satri-cel granted priority review by the NMPA. News release. CARsgen Therapeutics Holdings Limited. May 28, 2025. Accessed July 7, 2025. https://www.carsgen.com/en/news/carsgen-s-satri-cel-granted-priority-review-by-the-nmpa/
4. CARsgen’s Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA. CARsgen. News release. March 3, 2025. Accessed July 7, 2025. https://www.carsgen.com/en/news/20250303/