CARSgen enrolls all patients in the gastric cancer therapy study

Satri-cel has shown promising results in previous early-stage clinical trials. Image credit: BongkarnGraphic / Shutterstock.

Chinese biotechnology company CARsgen has completed enrollment in China for its Phase II trial of Satri-Cel, a potential first-in-class CAR-T cell therapy for advanced gastric cancer.

The study is evaluating the efficacy and safety of Satri-Cel in treating patients with advanced gastric/gastroesophageal junction (GC/GEJ) cancer who have exhausted other treatment options.

Satri-cel is a Claudin18.2 CAR-T cell therapy that targets Claudin18.2, a protein commonly found in GC/GEJ and pancreatic cancer cells.

The open-label, multicenter, randomized study will compare the effects of Satri-Cel with those of standard therapies chosen by physicians, including paclitaxel, docetaxel, irinotecan, apatinib and nivolumab.

Dr. Zonghai Li, Founder, Chairman, CEO and Chief Scientific Officer of CARsgen Therapeutics, said: “We are very pleased to announce the successful completion of patient enrollment for the pivotal Phase II clinical trial of Satri-Cel in China.

“This important milestone represents another important advance in our development of CAR-T cell therapies for solid tumors.

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“We look forward to submitting an application for approval of a new drug in China to help patients with stomach cancer.”

Satri-cel has already shown promising results in early-stage clinical evaluations.

In the Phase I study CT041-CG4006, the drug was described as well tolerated. No dose-limiting toxicities, severe cytokine release syndrome or immune effector cell-related neurotoxicity syndrome were reported.

Efficacy data from the same study showed an overall response rate of 54.9% in 51 GC/GEJ patients treated with satri-cel, with a disease control rate of 96.1% and a median duration of response of 6.4 months.

Phase Ib results from study CT041-ST-01 demonstrated overall response and disease control rates of 57.1% and 78.6%, respectively, in GC/GEJ patients who had previously undergone at least two lines of therapy.

Ongoing studies for Satri-cel include the investigator-initiated studies CT041-CG4006 and NCT03874897, as well as a confirmatory Phase II clinical trial for advanced GC/GEJ in China.

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