CARsgen Therapeutics has enrolled the first subject in the confirmatory Phase II clinical trial of its autologous CAR T-cell therapy candidate, CT041, to treat CLDN18.2 positive advanced gastric/gastroesophageal junction cancer (GC/GEJ).

The first patient was enrolled at the Beijing Cancer Hospital in China. 

GC/GEJ patients who have failed a minimum of two previous lines of treatments will be part of the trial.

An autologous CAR T-cell product against the protein Claudin18.2 (CLDN18.2), CT041 is being analysed to treat CLDN18.2 positive solid tumours with an initial focus on GC/GEJ and pancreatic cancer (PC).

The latest development comes after the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted approval to begin the trial in GC/GEJ patients. 

The trial will analyse the safety and efficacy of CT041 to treat advanced GC/GEJ patients.

CT041 is claimed to be the only CLDN18.2-targeting CAR T-cell product candidate to enter a Phase II trial for solid tumour treatment.

It also showed favourable safety in ongoing trials.

The CAR T-cell therapy candidate obtained the US Food and Drug Administration’s (FDA) Orphan Drug designation and Orphan Medicinal Product designation from the European Medicines Agency to treat GC/GEJ and advanced GC in 2020 and 2021. 

Apart from the confirmatory trial in China, CARsgen commenced a Phase Ib trial of the product to treat advanced GC/GEJ and PC in China and another Phase Ib trial for advanced gastric or pancreatic adenocarcinoma in North America.

The company plans to carry out a pivotal Phase II trial in North America this year.

CARsgen Therapeutics founder, board chairman, CEO and chief scientific officer Dr Zonghai Li said: “In the following clinical trials, we will further explore the efficacy and safety of CT041 in the treatment of advanced gastric/gastroesophageal junction cancer, as well as pancreatic cancer.

“We hope that CT041, a potential first-in-class CAR T-cell therapy, could make considerable progress and meet the unmet medical needs as soon as possible.”

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