The FDA on Tuesday placed a clinical hold on Bellicum Pharmaceuticals' T-cell therapy trial after three patients developed encephalopathy, reports Genetic Engineering and Biotechnology News.
Bellicum was testing the efficacy of BPX-501, an experimental T-cell therapy, to treat blood cancers and inherited blood disorders.
The FDA paused the trial after three patients experienced encephalopathy, a broad term for brain disease, damage or malfunction.
Bellicum acknowledged the encephalopathy cases may be related to the experimental treatment, but noted the three patients who developed the complications had particularly complex medical cases.
“Bellicum is awaiting formal communications from the FDA to determine the requirements for resuming studies, and will be working closely with the FDA to address their questions," the company said Tuesday.
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