FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to Autolus’ CAR T Cell Therapy, Obe-Cel, for the Treatment of Adult B-ALL

Autolus Therapeutics plc announced that the US FDA has granted RMAT designation to its lead gene therapy obecabatagene autoleucel, a CD19-directed autologous chimeric antigen receptor (CAR) T therapy that is being investigated in the ongoing FELIX Phase II study of adult relapsed/refractory B-acute lymphocytic leukemia (B-ALL).