FDA Lifts Holds on “Off-the-Shelf” CAR-T Trials

November 7, 2017 – The FDA today lifted clinical holds placed on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell (UCART) therapy known as UCART123. The agency halted UCART trials in September following the death of a 78-year-old man being treated for blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA also cited the case of a 58-year-old woman who developed grade 3 cytokine release syndrome (CRS) and grade 4 capillary leak … (leggi tutto)