The FDA has instituted a clinical hold on Legend Biotech Corporation's (NASDAQ:LEGN) Phase 1 trial for LB1901.
- LB1901 is the company's investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for relapsed or refractory T-cell lymphoma (TCL).
- The FDA indicated they would provide an official clinical hold letter to Legend Biotech by March 11.
- Related content: Benzinga's Full FDA Calendar.
- To date, one patient has been dosed in the clinical trial.
- Before receiving the FDA's clinical hold communication, Legend Biotech had, under 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.
- Price Action: LEGN shares are up 0.18% at $39.79 during the market session on the last check Tuesday.
