The Food and Drug Administration placed a clinical hold on two of Collectis' clinical trials for an immunotherapy drug after a patient's death, reports Genetic Engineering & Biotechnology News.
Here are six things to know.
1. UCART 123 is an experimental chimeric antigen receptor T-cell drug intended to genetically alter a patient's immune cells to attack cancer.
2. Collectis was testing the drug in patients with blastic plasmacytoid dendritic cell neoplasm — a rare type of blood cancer — and acute myeloid leukemia.
3. A 78-year-old man participating in the BPDCN trial died nine days after receiving his first dose of UCART 123. The patient experienced cytokine release syndrome, a potentially fatal immune reaction to the therapy.
4. An adverse event also occurred in a 58-year-old woman participating in the clinical trial for AML patients. She received the same dose of UCART 123 as the male patient in the BPDCN trial. Nine days after her first dose, the woman also experienced cytokine release syndrome, which resolved on day 11.
5. The FDA's clinical hold applies to both the BPDCN study and the AML study.
6. Collectis is working with the FDA and investigators to update protocols before resuming the clinical trials. The drugmaker will likely lower dosing levels for UCART 123.
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