{"id":10769,"date":"2024-11-01T16:16:33","date_gmt":"2024-11-01T08:16:33","guid":{"rendered":"https:\/\/flcube.com\/?p=10769"},"modified":"2024-11-01T16:16:37","modified_gmt":"2024-11-01T08:16:37","slug":"carsgen-therapeutics-suspended-car-t-therapies-get-fda-green-light-to-resume","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10769","title":{"rendered":"CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume"},"content":{"rendered":"\n

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<\/a>), 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).<\/p>\n\n\n\n

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<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for…<\/p>\n","protected":false},"author":1,"featured_media":10770,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,21,379,77,1188],"class_list":["post-10769","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-car-t","tag-carsgen-therapeutics","tag-cell-therapy","tag-hkg-2171"],"yoast_head":"\nCARsgen Therapeutics' Suspended CAR-T Therapies Get FDA Green Light to Resume - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"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. 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