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news.Bellicum Pharmaceuticals has completed dosing in the first cohort of patients in the BP-004 Phase I/II trial with its genetically engineered donor T cells (BPX-501), after receiving a partial T depleted haplo-identical allogeneic hematopoietic stem cell transplant (haplo-HSCT).
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The ongoing multi-center, open label dose escalation BP-004 trial is being held at leading transplant centers in Europe and in the US.
Phase I arm of the trial includes three cohorts of three to six patients, each receiving escalating doses of BPX-501 T cells following haplo-HSCT.
The trial’s Phase II extension arm will use the highest tolerated Phase I dose, with a maximum of 30 patients in both phases.
Pediatric patients, aged three months to 21 years, diagnosed with blood cancers, immune deficiencies or inherited hematologic disorders are enrolled in the trial.
The trial is evaluating whether BPX-501 T cells from partially mis-matched donors administered following HSCT are safe and can help speed immune reconstitution.
The company said that BPX-501 contains the CaspaCIDe safety switch that offers doctors the ability to eliminate the T cells should they cause Graft-versus-host disease, a more common occurrence with a haplo-HSCT than with a matched procedure.
Bellicum CEO Tom Farrell said: "We believe BPX-501 may have the potential to make alternative donor haplo-identical stem cell transplants as routine as conventional transplants from matched donors, enabling a treatment known to be curative, and making it available for many more patients suffering from a wide range of deadly and life-long diseases."
The trial is also designed to evaluate the treatment of Graft-versus-host disease (GvHD) in transplant patients who have received BPX-501 by infusion of the small molecule, dimerizer drug rimiducid.