FDA issues clinical hold on Legend Biotech's its Phase I LB1901 trial

US clinical-stage biotech Legend Biotech Corporation (Nasdaq: LEGN) managed to close up 2.2% yesterday, despite announcing that, on Friday, February 11, the company was informed by the US Food and Drug Administration (FDA) via email communication that its Phase I clinical trial for LB1901 has been placed on clinical hold.

LB1901 is the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL). The FDA indicated it will provide an official clinical hold letter to Legend by March 11, 2022. To date, one patient has been dosed in the clinical trial.

Before receiving the FDA’s clinical hold communication, Legend had, in accordance with the protocol, paused the clinical trial due to low CD4+ T-cell counts in the patient’s peripheral blood and notified the FDA. The patient has not experienced drug-related serious adverse events (SAEs) and is being monitored in accordance with the protocol.