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The US Food and Drug Administration (FDA) has lifted the clinical hold due to a patient death on Phase I testing of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Cellectis S.A. (Paris, New York), the developer of a first-in-class gene-edited allogeneic CAR T-cell (UCART) therapy announced it has agreed with the agency to implement several revisions. The company said it is currently working with the investigators and clinical sites to obtain IRB‘s approval on the revised protocols and resume patient enrollment.