FDA Lifts Clinical Hold on Studies of BPX-501
Posted: Monday, April 16, 2018
On April 11, Bellicum Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) lifted the clinical hold on studies of BPX-501 in the United States. The decision follows consultation with the FDA and agreement on amendments to the study protocols, including guidance on monitoring and managing neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols.
BPX-501 is an adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplantation (HSCT), comprising genetically modified donor T cells incorporating the manufacturer’s CaspaCIDe® safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of the activator agent rimiducid) should uncontrollable graft-versus-host disease or other T-cell–mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501–engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing the side effects of graft-versus-host disease.
On January 30, studies of BPX-501 were placed on a clinical hold following three cases of encephalopathy deemed possibly related to the treatment. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.
