Posted by Michael Wonder on 02 May 2023
Cabaletta Bio receives FDA fast track designation for CABA-201
1 May 2023 - Cabaletta Bio today announced that the US FDA has granted fast track designation for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, designed to deplete CD19-positive B cells and improve disease activity in patients with systemic lupus erythematosus and lupus nephritis.
CABA-201 is designed to be given as a one-time infusion, to evaluate its potential to transiently, but fully, eliminate B cells, enabling an “immune system reset” with durable remission in patients with systemic lupus erythematosus.
