October 5, 2020 -- CARsgen Therapeutics has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for CT041, a humanized anti-claudin18.2 autologous chimeric antigen receptor (CAR) T-cell product, targeting claudin18.2-positive cancers.
CT041 is the first claudin18.2-targeted CAR T-cell therapy to receive investigational new drug (IND) clearance by the FDA and the National Medical Products Administration (NMPA) in China. The therapy is currently being investigated in an open-label, multicenter phase IB clinical trial in patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma.
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