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# CARsgen Gains Regenerative Medicine Advanced Therapy Status
- URL: https://www.fdaweb.com/carsgen-gains-regenerative-medicine-advanced-therapy-status/
- Published: 2019-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:51:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145395

FDA has granted CARsgen Therapeutics a Regenerative Medicine Advanced Therapy designation for its investigational CT053 CAR-T cell therapy and its use in treating relapsed and refractory multiple myeloma. The designation for the drug, a human anti-B cell maturation antigen, was based on clinical data from an ongoing Phase 1 study in heavily pre-treated multiple myeloma patients in China. Updated data from the study will be presented at the American Society of Hematology annual meeting in Orlando on 12/9.