CT041 is being studied to treat gastric, pancreatic, and digestive system cancers. Credit: Meletius Verras / Shutterstock.

CARsgen Therapeutics and Moderna have collaborated to evaluate Claudin18.2 CAR T-cell product candidate CT041 together with the off-the-shelf mRNA cancer vaccine.

The parties will carry out preclinical studies and a Phase I clinical trial for assessing the combination therapy.

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CARsgen’s autologous product CT041 (satricabtagene autoleucel) is being studied to potentially treat patients with gastric, pancreatic, and other specified digestive system cancers.

CARsgen Therapeutics founder, board chairman, CEO and chief scientific officer Dr Zonghai Li said: “CT041 is the most advanced solid tumour CAR-T in development (pivotal phase II) and continues to show promise in treating gastric and pancreatic cancers (PC).

“In our quest to make cancer curable, we are continuously exploring multiple modalities to eradicate tumours.

“Attacking tumours with CAR T-cell therapy in combination with a cancer vaccine could potentially provide greater clinical benefit to patients.”

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Multiple clinical studies of CT041 are currently ongoing in China, including a Phase Ib trial for advanced gastric cancer/ gastroesophageal junction cancer (GC/GEJ) and PC, a Phase I study for PC adjuvant therapy, and a confirmatory Phase II clinical trial for advanced GC/GEJ.

The US Food and Drug Administration (FDA) granted regenerative medicine advanced therapy designation to CT041 last January for treating advanced GC/GEJ with Claudin18.2-positive tumours.

A Phase Ib/II trial for advanced gastric or pancreatic adenocarcinoma is also currently underway in North America.

Moderna External Research Ventures chief scientific officer Dr Lin Guey said: “Claudin18.2 is a promising therapeutic target to potentially treat multiple cancer types with high unmet medical needs.

“We continue to deliver on the promise of mRNA science to create a new generation of transformative medicines in oncology.”

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