Posted by Michael Wonder on 13 Feb 2023
IASO Bio announces CT103A granted regenerative medicine advanced therapy and fast track designations by the FDA
12 February 2023 - IASO Biotherapeutics today announced that the US FDA has granted both regenerative medicine advanced therapy designation and fast track designation to its investigational new drug BCMA CAR-T CT103A (Equecabtagene autoleucel) for relapsed/refractory multiple myeloma.
Equecabtagene autoleucel (CT103A) is a BCMA chimeric antigen receptor autologous T cell injection, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains.
