The FDA placed a clinical hold on drug research conducted by Athenex, a biotech company based in Buffalo, N.Y., after a patient died during a phase one trial, the company said March 20.
In a news release updating investors on its 2022 financial results, Athenex said the FDA imposed a clinical hold on its KUR-501 investigational new drug application "following the death of a young, heavily pretreated male patient with (relapsed and refractory high risk neuroblastoma) treated at the fifth dose level of 300 million cells divided by body surface area."
The study participant died three weeks after receiving CAR-NKT cell therapy. Houston-based Baylor College of Medicine, the drug application's sponsor, is investigating, according to Athenex.
The trial was investigating the cell therapy for patients with relapsed and refractory high risk neuroblastoma, which happens in about 50 percent of children treated for neuroblastoma, according to Boston's Children Hospital.
Athenex said the "subject was found to have human metapneumovirus infection, then Grade 1 cytokine release syndrome that was treated with immunosuppressants," and he "later developed polyclonal hyperleukocytosis complicated by multiorgan dysfunction without evidence of sepsis."
Baylor College of Medicine is making a safety risk mitigation plan to resume the clinical trial and exclude participants with concomitant viral infections, Athenex said, but there are no guarantees the clinical hold will be lifted and a resuming date cannot be predicted.
Athenex said it is "working closely with Baylor College of Medicine to help address the FDA's questions and remains committed to the continued safe clinical development of what it believes is a promising new CAR-NKT cell therapy product for a high unmet medical need in a pediatric orphan indication."