ARTICLE | Clinical News

FDA lifts clinical hold on Cellectis' CAR T candidate

November 17, 2017 8:46 PM UTC

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) said FDA lifted a clinical hold on Phase I testing of its chimeric antigen receptor (CAR) T cell candidate UCART123 to treat acute myelogenous leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). Cellectis agreed to several revisions of Phase I protocols in order to lift the hold, which FDA placed in September following a patient death (see BioCentury, Sept. 8).

The biotech agreed to reduce dose levels in 2 studies to 6.25x104 cells/kg. A 78-year-old male patient in the Phase I ABC study of UCART123 died 9 days after receiving a single IV infusion of 6.25x105 cells/kg following preconditioning with fludarabine and cyclophosphamide, despite treatment with corticosteroids and Actemra tocilizumab plus intensive care unit (ICU) support. The patient developed grade 5 cytokine release syndrome (CRS) and grade 4 capillary leak syndrome (CLS)...