Two ongoing CAR-T Phase I trials of Cellectis drug candidate has been put on hold by FDA after a patient’s death
FDA has put two CAR-T trials on hold following a patient’s death, less than a week after the first ever CAR-T was approved by the US regulatory agency. The patient (78) was suffering from relapsed blastic plasmacytoid dendritic cell neoplasm (BPDCN). The patient died 9 days after the administration of Cellectis’ UCART123 after experiencing severe cytokine release syndrome (CRS) and a grade 4 capillary leak syndrome (CLS), complications that are commonly associated with CAR-T therapies.
ContraVir Pharmaceuticals Announces Clinical ...
