SOMERSET, N.J.– Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, today announced that on Friday, February 11, 2022, the company was informed by the U.S Food and Drug Administration (FDA) via e-mail communication that its Phase 1 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 they will provide an official clinical hold letter to Legend Biotech by March 11, 2022.
To date, one patient has been dosed in the clinical trial. Before receiving the FDA’s clinical hold communication, Legend Biotech 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.
egend Biotech is a global, clinical-stage biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
