CT041 is intended for the treatment of CLDN18.2 positive advanced gastric cancer/gastroesophageal junction cancer. Credit: PopTika / Shutterstock.

Chinese biotechnology company CARsgen Therapeutics has started a Phase II clinical trial of CT041 in the US, enrolling patients with Claudin18.2 (CLDN18.2) positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ).

CT041 is an autologous chimeric antigen receptor (CAR) T-cell product candidate that targets the CLDN18.2 protein.

The trial will evaluate CT041 in treating individuals with CLDN18.2 positive advanced GC/GEJ who have failed two or more previous lines of systemic treatments.

CARsgen chief medical officer Dr Raffaele Baffa said: “Gastric cancer is a devastating disease that affects over a million people worldwide.

“Despite advances in treatment, the prognosis for patients with advanced gastric cancer remains poor, highlighting the urgent need for new and innovative therapies.

“CT041 has shown promising results in previous trials, demonstrating clinical efficacy and a manageable safety profile.

“We believe that CT041 has the potential to become an effective treatment option for patients with advanced gastric cancer.

“We would also like to express our gratitude to the patients, investigators, and our dedicated team at CARsgen for their commitment to advancing the field of cancer immunotherapy.

“We look forward to sharing updates on our clinical progress as we continue to work towards our goal of developing innovative CAR T-cell therapies for patients.”

Along with GC/GEJ treatment, CT041 targets CLDN18.2-positive solid tumours with a key focus on pancreatic cancer.

CARsgen is also engaged in investigator-initiated trials, including a confirmatory Phase II trial for advanced GC/GEJ in China and a Phase Ib/II trial for advanced gastric or pancreatic adenocarcinoma in North America.

Earlier this year, CARsgen Therapeutics and Roche entered a collaboration agreement to assess AB011, along with atezolizumab, for the treatment of gastric cancer.

Roche has agreed to handle the operations and conduct the trial, while both companies will share the costs of the study’s AB011 treatment arms.

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