Posted by Michael Wonder on 28 Oct 2019
CARsgen announces investigational CAR-T therapy CT053 granted RMAT designation by the U.S. FDA for relapsed/refractory multiple myeloma
28 October 2019 - CARsgen Therapeutics today announced that the United States FDA has granted regenerative medicine advanced therapy designation to its investigational CT053 CAR-T cell therapy.
CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma.
RMAT designation was based on clinical data from an ongoing CT053 phase 1 study in heavily pre-treated multiple myeloma patients in China.
