Bellicum today announced that the U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT (hematopoietic stem cell transplants), comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe® safety switch. It is designed to provide a safety net to eliminate alloreactive (reaction in response to transplanted tissue) BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD 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 GvHD side effects.
Bellicum announced the clinical hold in January of 2018 after 3 patients developed encephalopathy possibly related to treatment with BPX-501. At the time, Bellicum was conducting four trials with BPX-501 in the US.
As of this writing, Bellicum shares were up over 25% in after hours trading.