FDA places clinical hold on Legend Biotech’s CAR-T for T-cell lymphoma
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The FDA placed a clinical hold on a phase 1 trial of LB1901, a chimeric antigen receptor T-cell therapy for treatment of adults with relapsed or refractory T-cell lymphoma.
LB1901 (Legend Biotech) is an autologous, gene edited CAR T-cell therapy that targets the CD4 protein on the surface of cancer cells.
The agency approved LB1901 for investigational use in December 2020. The multicenter study includes patients with relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma.
The study’s hold comes after the first patient treated with the cell therapy experienced low CD4+ T-cell counts.
“Legend Biotech had, in accordance with the [study] protocol, paused the clinical trial due to low CD4+ T-cell counts in the patient’s peripheral blood and notified the FDA,” the manufacturer said in a press release “The patient has not experienced drug-related serious adverse events and is being monitored in accordance with the protocol.”
Legend Biotech said it found out about the hold via an email, adding that the FDA advised it would receive an official clinical hold letter by March 11, 2022.
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