CARsgen's Satri-cel: A Breakthrough in Gastric Cancer Treatment

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) has announced positive topline results from its pivotal Phase II clinical trial of Claudin18.2 CAR-T (Satri-cel) in China for gastric cancer/gastroesophageal junction (GC/GEJ) patients. The trial, CT041-ST-01, demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with Satri-cel compared to treatment of physician's choice. This breakthrough in CAR-T therapy for solid tumors brings hope to patients and the medical community alike.



The open-label, multicenter clinical trial evaluated the safety and efficacy of Satri-cel in subjects with Claudin18.2 expression-positive, advanced GC/GEJ cancers who had failed at least two prior lines of therapy. Patients were randomly assigned 2:1 to receive either Satri-cel infusion or treatment of physician's choice, which included paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab. The primary endpoint of the trial was PFS assessed by the Independent Review Committee (IRC).

The positive results from the CT041-ST-01 trial build on the encouraging safety and efficacy data from the investigator-initiated trial CT041-CG4006, which was published in Nature Medicine and presented at the 2024 ASCO Annual Meeting. The final results of CT041-CG4006 demonstrated the potential of Satri-cel in treating advanced gastrointestinal cancers, particularly those with gastric cancer or gastroesophageal junction cancer.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, expressed his enthusiasm about the positive results: "We are thrilled to see that satri-cel has achieved positive results in the pivotal Phase II clinical trial in China. The study demonstrates that satri-cel provides significant benefits to gastric cancer patients who have failed at least two prior lines of therapy. This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors. We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world’s first CAR-T product for solid tumors, bringing hope to more patients as soon as possible."



CARsgen's proprietary CARcelerate® platform, which shortens the manufacturing time to approximately 30 hours, has contributed to the success of Satri-cel. The platform results in younger and potentially more potent CAR T cells compared to conventional manufacturing processes. Additionally, CARsgen is exploring the potential of Satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients.

The manageable safety profile of Satri-cel, as demonstrated in the clinical trials, is a significant factor in its potential market adoption and patient accessibility. The positive results from the CT041-ST-01 trial, coupled with the manageable safety profile, suggest that Satri-cel could become a valuable addition to the treatment landscape for gastric cancer patients who have failed at least two prior lines of therapy.

In conclusion, CARsgen's Satri-cel has shown promising results in the treatment of gastric cancer, with a manageable safety profile and the potential to transform the treatment paradigm for patients with advanced GC/GEJ. As CARsgen continues to advance the global clinical development of Satri-cel, it brings hope to more patients with gastric, pancreatic, and other gastrointestinal cancers.