FDA Grants Investigational New Drug Approval for CAR T-Cell Therapy

The U.S. Food and Drug Administration (FDA) approved an Investigational New Drug Application for UCART123, a gene-edited chimeric antigen receptor (CAR) T-cell therapy targeting CD123. As part of this approval, UCART123 will be evaluated in a phase I clinical trial of patients with acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. The trial is expected to begin in the first half of this year.

Sources: Cellectic press release, February 6, 2017; Reuters, February 6, 2017.