#China #Shanghai #pancreatic cancer #CARsgen #Satri-cel

CARsgen Therapeutics Presents Groundbreaking Findings on Satri-cel for Pancreatic Cancer at ESMO 2025

Introduction to Satri-cel
At the 2025 European Society for Medical Oncology (ESMO) Congress, CARsgen Therapeutics Holdings Limited, a pioneering company in CAR T-cell therapy, showcased the preliminary results of their Phase Ib clinical trial of Satri-cel, an innovative CAR T-cell therapy targeting Claudin18.2 for pancreatic cancer treatment. This session illustrated a potential breakthrough in adjuvant therapy for this highly challenging form of cancer.

The Significance of the Study
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies. Even after surgical removal, the risk of local and distant recurrence is alarmingly high. Consequently, there is a pressing need for effective adjuvant therapies that can substantially reduce this risk. The trial, identified as CT041-ST-05 and registered under NCT05911217, is notable for being the world's first proof-of-concept exploration into CAR T-cell therapy for solid tumors like pancreatic cancer.
Professor Xianjun Yu, from the Fudan University Shanghai Cancer Center, spearheaded the research, which was aimed at patients with Claudin18.2-positive PDAC who faced the risk of recurrence after surgery. Given the limited effectiveness of current therapies, the trial was designed to explore a transformative therapeutic approach.

Trial Details and Early Findings
The trial enrolled patients showing abnormal carbohydrate antigen 19-9 (CA19-9) levels post-surgery, indicating a high risk of cancer recurrence. Between September 15, 2023, and April 11, 2025, six patients received Satri-cel infusion. Following a median follow-up duration of 6.05 months, the results were promising: only one patient exhibited recurrence of the disease, while the remaining participants maintained disease-free status. The study achieved a 9-month disease-free survival (DFS) rate of 83.3%, a remarkable statistic considering the aggressive nature of PDAC. Furthermore, significant reductions in CA19-9 levels were noted in five out of six patients, highlighting Satri-cel's potential in reducing residual cancer.

Safety Profile and Side Effects
While Satri-cel appeared to show promise in terms of efficacy, its safety profile was also documented. Most patients experienced Grade 1 or 2 cytokine release syndrome (CRS), an expected reaction following CAR T-cell therapy. One patient did experience a severe occurrence of Grade 3 CRS, which was managed effectively with tocilizumab. Gastrointestinal disturbances such as nausea and vomiting were also reported, but they remained manageable at lower grades. Importantly, no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported, indicating that Satri-cel is relatively safe compared to some alternative therapies.

Future Directions for Satri-cel
Dr. Zonghai Li, Founder and CEO of CARsgen, expressed excitement regarding Satri-cel's preliminary efficacy and its implications for pancreatic cancer treatment. Recognizing the dearth of effective therapies for high-risk patients post-surgery, he emphasized the potential of Satri-cel to address minimal residual disease and improve treatment outcomes significantly. Looking ahead, CARsgen is planning to extend clinical trials utilizing Satri-cel for gastric cancer and as a follow-up option after conventional treatments, aiming to broaden its applicability and offer hope to a larger patient population suffering from cancer.

Conclusion
The preliminary results of the Satri-cel study underscore the potential of CAR T-cell therapies to transform the treatment landscape for pancreatic cancer. With its unique targeting approach and encouraging outcomes, CARsgen Therapeutics is paving the way for new adjuvant therapies that could enhance survival rates and improve quality of life for patients globally.

About CARsgen Therapeutics
CARsgen is committed to developing innovative CAR T-cell therapies that meet the urgent needs of patients battling hematologic malignancies, solid tumors, and autoimmune diseases. Their mission is to become a leader in providing differentiated cellular therapies that can cure diseases previously deemed untreatable.

Forward-Looking Statements
This release contains forward-looking statements that reflect the companies' current expectations and may involve risks and uncertainties affecting outcomes. The actual performance and results could vary significantly from those expressed, requiring careful consideration of various factors and assumptions.