The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy approved in China in February to treat relapsed refractory myeloma; CT041 (satricabtagene autoleucel), a Claudin18.2-targeted CAR-T product; and CT071, a CAR-T therapy developed via the CARcelerate platform targeting G protein-coupled receptor class C group 5 member D (GPRC5D).
In December 2023, CARsgen was notified by the FDA to halt the clinical studies for these products. The company committed to conducting a comprehensive inspection and improving its facilities in accordance with current Good Manufacturing Practice (cGMP) and pledged close cooperation with the FDA to address any issues. A Corrective And Preventive Actions (CAPAs) report was submitted to the FDA in April, followed by a filing to lift the hold on the trials last month.- Flcube.com
