CARsgen receives IND clearance for cell therapy

By The Science Advisory Board staff writers

May 18, 2020 -- CARsgen Therapeutics has received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a cell therapy drug for advanced gastric and pancreatic cancer.

The drug, called CT041 humanized anti-claudin18.2 autologous chimeric antigen receptor (CAR) T cells (CT041), is the first of its kind cleared for clinical trials in the world, CARsgen said. The IND clearance was supported by a phase I trial conducted at Beijing Cancer Hospital at Peking University in China. A phase 1b trial will begin in the third quarter of this year, according to the firm.

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