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FDA Puts Clinical Holds on Trials of BPX-501

Jason Harris
Published: Wednesday, Jan 31, 2018

The FDA has halted 4 US studies of BPX-501, a novel cellular immunotherapy for cancers and orphan inherited blood disorders, after 3 patients developed encephalopathy possibly related to treatment with BPX-501.

Bellicum Pharmaceuticals is currently conducting 4 phase I/II clinical trials of BPX-501 in the United States:
  • BP-001 and BP-005: adults with hematological cancers in which BPX-501 is administered after initial allogeneic hematopoietic stem cell transplantation (HSCT);
  • BP-003: children with orphan inherited blood disorders in which BPX-501 is administered after initial allogeneic HSCT;
  • BP-008: adults and children with blood cancers to treat post-transplant relapse and evaluate the potential for a titrated dose of rimiducid to resolve uncontrolled graft-versus-host disease (GVHD) while preserving BPX-501 cells.
The company reported in a press release that the clinical hold does not affect its European BP-004 trial exploring BPX-501 following initial allogeneic HSCT in children with hematological cancers or orphan inherited blood disorders.

The overall pattern of immune recovery in the 112 children studied may be improved when compared to patients who received a similar haplo-HSCT without BPX-501, according to the investigators. Neither acute GVHD nor leukemia recurrence occurrence statistically affected the number of BPX-501 cells.
Merli P, Bertaina V, Galaverna F, et al. Donor T cells genetically modified with a novel suicide gene (inducible Caspase 9, iC9) expand and persist over time after post-allograft infusion in patients given αβ T-cell and B-cell depleted HLA-haploidentical allogeneic stem cell transplantation (αβ haplo-HSCT) contributing to accelerate immune recovery. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta. Abstract 211.

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