The company says this is the first CAR T-cell therapy aimed at giving doctors better control over cell activity and prevent cells from dying when the protein to which they were designed to react against is not present.
BPX-601 includes the GoCAR-T cells, a type of CAR T-cells that have been modified to include a dual co-stimulatory domain activation switch. In other words, while standard CAR T-cells are activated solely by the presence of the cancer antigen to which the cells are directed, in GoCAR T-cells, a rimiducid-controlled switch also controls cell activation. This enables T-cells to survive in the absence of cancer antigens and proliferate the presence of cancer antigens.
In addition, GoCAR T-cell are safer than standard CAR T-cells, the company says, because the levels of activation of these cells may be reduced by slowing down the rimiducid dosing schedule.
The BP-012 Phase 1 trial (NCT02744287) is an open-label, non-randomized, dose-finding study designed to assess the safety and efficacy of BPX-601 plus rimiducid in up to 30 patients with non-resectable, or non-operable, pancreatic cancer.
“We believe the initiation of the BPX-601 clinical study is an important milestone in the advancement of CAR T therapies,” Rick Fair, president and CEO of Houston-based Bellicum, said in a news release. “The ability to control the intensity and duration of a cell-based treatment may help address the limitations that current CAR T therapies face, especially when targeting solid tumors.”
The trial will take place at Baylor University Medical Center in Dallas. It will determine the safety of BPX-601 administration, the safety of rimiducid infusion and the persistence of the CAR-T cells over time after a single rimiducid infusion.
“This clinical trial is an important step in our ongoing research efforts to improve patient outcomes in one of the deadliest forms of cancer,” said Carlos Becerra, MD, Baylor’s interim chief of oncology and the study’s principal investigator. “The pancreatic cancer patients who will be eligible to participate in the study have progressed after standard treatments and have limited options.”