Bellicum Pharmaceuticals ends CAR-T trials for solid tumors after risk-benefit review
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Bellicum Pharmaceuticals discontinued clinical trials for two investigational chimeric antigen receptor T-cell therapies in development for solid tumors, the company announced today.
The decision applies to phase 1/phase 2 trials designed to evaluate the safety and preliminary efficacy of the company’s GoCAR-T cell product candidates — BPX-601 and BPX-603 — in combination with the small molecule inhibitor rimiducid (Bellicum Pharmaceuticals) for heavily pretreated individuals with cancer.
BPX-601 is a prostate stem cell antigen (PSCA)-directed CAR-T. BPX-603 is a HER2-targeted CAR-T for treatment of metastatic solid tumors that express high levels of HER2.
In December 2020, the FDA placed a clinical hold on a trial for BPX-601 and rimiducid for patients with previously treated advanced solid tumors that express high levels of PSCA after the manufacturer reported the death of one study participant with pancreatic cancer. The FDA lifted the clinical hold 2 months later after an investigation showed the death had been unrelated to either study drug.
The most recent patient treated in the dose-escalation trial of BPX-601 — a man with metastatic castration-resistant prostate cancer — experienced serious immune-mediated adverse events, including grade 4 cytokine release syndrome, according to a Bellicum Pharmaceuticals-issued press release.
This finding — the second dose-limiting toxicity investigators observed in the trial’s active treatment cohort — prompted the company to halt enrollment of its trials and perform a review of the risk-benefit profile of the rimiducid-BPX-601 combination observed to date.
“[Although] clinically meaningful efficacy has been observed ... the company believes it does not have the necessary resources to optimize either the clinical dose and schedule of BPX-601 cells and the activating agent rimiducid, or the design of the BPX-601 cell construct to achieve a favorable risk-benefit profile,” the press release stated.
The discontinuations will affect researchers and patients at more than a dozen trial sites across the United States.
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