After a study participant died from a severe and rare inflammatory syndrome, the FDA placed a partial clinical hold on a France-based drugmaker's cancer drug trial.
The fatal case involved hemophagocytic lymphohistiocytosis, a hematologic disorder that "can sometimes occur in normal people with medical problems that can cause a strong activation of the immune system, such as infection or cancer," according to the Immune Deficiency Foundation.
The FDA's hold means Innate Pharma is barred from recruiting new participants in its ongoing phase 1 and phase 2 research of lacutamab, an experimental therapy for cutaneous T-cell lymphoma. In an Oct. 5 news release, Innate said it already finalized enrollment in both studies, with 20 people in phase 1 and 170 in phase 2.
"Patients already on [lacutamab] who are deriving clinical benefit may continue treatment after being reconsented," the release said, adding that the company is working to mitigate the risk of the hematologic disorder and expects trial data to be released by the end of 2023.