FDA lifts clinical hold on trial of CAR-T for metastatic pancreatic, prostate cancers
The FDA lifted its clinical hold on a study evaluating BPX-601 and rimiducid for patients with previously treated metastatic pancreatic or prostate cancers, according to a press release from the agent’s manufacturer.
BPX-601 (Bellicum Pharmaceuticals) is an autologous chimeric antigen receptor T-cell therapy that targets tumor cells expressing high levels of prostate stem cell antigen (PSCA).
The investigational therapy uses Bellicum’s proprietary dual-switch GoCAR-T, which allows clinicians to either activate or eliminate the CAR T cells with the administration of small molecules to enhance real-time control of the agent.
The small molecule being used in the study is rimiducid (Bellicum Pharmaceuticals), an investigational lipid-permeable tacrolimus analogue with homodimerizing activity.
Researchers designed the phase 1/phase 2 dose-escalation trial to evaluate the safety and efficacy of BPX-601 and rimiducid among patients with previously treated advanced solid tumors — including pancreatic, stomach or prostate tumors — that express high levels of PSCA.
The agency placed the trial on hold in December after the manufacturer reported the death of one participant with pancreatic cancer. The study investigator determined the death to be unrelated to either study drug.
Bellicum has worked with the FDA to address issues related to the clinical hold and will be permitted to resume enrollment in the trial without modification to the study’s protocol, according to the release.
“I am pleased that our team was able to address the FDA’s clinical hold questions in a timely manner, enabling us to evaluate BPX-601 in a cohort of patients with previously treated metastatic prostate cancer,” Rick Fair, president and CEO of Bellicum, said in the release. “I remain optimistic about the safety and potential clinical benefit of our BPX-601 product candidate in these patients.”