6 August 2025 - Galapagos today announced that the US FDA has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma.
Clinical data derived from the on-going ATALANTA-1 study with GLPG5101 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL), including a subset of patients with MCL, supported the designation.