FDA grants orphan drug designation to CAR T-cell therapy for advanced gastric cancers

The FDA granted orphan drug designation to CT041 for the treatment of adults with relapsed or refractory gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.CT041 (CARsgen Therapeutics) is an autologous chimeric antigen receptor T-cell therapy that targets claudin 18.2, a stomach-specific isoform of claudin 18 that is highly expressed in gastric adenocarcinoma.As Healio previously reported, the FDA cleared the investigational new drug application for CT041 earlier this year.The clearance was based on phase 1 results of a clinicalRead More

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