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

September 5, 2017 – Following the death of a 78-year-old man being treated for blastic plasmacytoid dendritic cell neoplasm (BPDCN), the FDA placed clinical holds on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell (UCART) therapy known as UCART123. The man died after experiencing cytokine release syndrome (CRS). A 58-year-old woman being treated for acute myeloid leukemia (AML) also developed CRS. Although his condition resolved … (leggi tutto)