CARsgen Therapeutics has secured the approval from the China National Medical Products Administration (NMPA)’s Center for Drug Evaluation (CDE) to start the Phase II clinical trial of CT041 to treat gastric/gastroesophageal junction cancer (GC/GEJ).

CT041 is an autologous chimeric antigen receptor (CAR) T-cell product candidate that targets the protein Claudin18.2 (CLDN18.2).

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The trial will analyse the safety and efficacy of CT041 to treat individuals with CLDN18.2-positive advanced GC/GEJ who failed a minimum of two previous lines of systemic treatments.

CARsgen Therapeutics founder, board chairman, CEO and chief scientific officer Dr Zonghai Li said: “With the approval of CT041 to initiate the confirmatory Phase II clinical trial of gastric cancer, we are one step further to successfully obtain the CT041 marketing authorisation. 

“With our continuous research and development, we believe that CT041 has a great potential to change the treatment paradigm for advanced gastric cancer worldwide.”

The company noted that CT041 targets treating CLDN18.2-positive solid tumours with a key focus on GC/GEJ and pancreatic cancer (PC).

In trials that are underway, CT041 was found to offer favourable therapeutic safety.

According to CARsgen, CT041 can become a backbone treatment for GC/GEJ and PC, benefiting a huge patient population globally.

In October 2019, the US Food and Drug Administration granted regenerative medicine advanced therapy (RMAT) designation to the company’s CT053 for the treatment of relapsed and refractory multiple myeloma (rrMM).

An autologous CAR T-cell treatment, CT053 is designed as a fully human anti-B Cell Maturation Antigen.