Posted by Michael Wonder on 12 Nov 2025
March Biosciences receives FDA regenerative medicine advanced therapy designation for MB-105 in relapsed/refractory CD5 positive T-cell lymphoma
11 March 2025 - March Biosciences today announced that the US FDA has granted regenerative medicine advanced therapy designation to MB-105, the Company’s first in class autologous CD5 targeted CAR-T cell therapy, in development for relapsed/refractory CD5 positive T-cell lymphoma.
The designation was granted based on data from March Bio’s on-going multi-centre Phase 2 clinical trial.
