Cellectis CAR-T Studies on Hold Following Death of First Patient

The FDA placed a clinical hold on Cellectis’ ongoing Phase I studies of a CAR-T therapy in acute myeloid leukemia and in blastic plasmacytoid dendritic cell neoplasms.

The hold was initiated after Cellectis reported the death of the first patient treated in the BPDCN study, following reports of cytokine release syndrome: a 78-year-old male treated with one prior therapy, with relapsed/refractory BPDCN with 30 percent blasts in his bone marrow and cutaneous lesions.

A data safety monitoring board recommended lowering the dose in both studies, the company said. Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123.