FDA Lifts Clinical Hold on Cellectis CAR-T Trials

Cellectis said the FDA has lifted the clinical hold placed in September on the company’s two Phase I studies of its universal gene-edited allogeneic chimeric antigen receptor T-cell (CAR-T) immunotherapy candidate UCART123 following the death of a patient in one of the trials.The FDA clinical hold, announced September 4, applied to a trial ( NCT03190278 ) assessing UCART123 in acute myeloid leukemia (AML)—as well as a trial assessing UCART123 in blastic plasmacytoid dendritic cell ne