FDA Slams Brakes On Legend Biotech's CAR-T Therapy Trial In Lymphoma Patients

The FDA has instituted a clinical hold on Legend Biotech Corporation's 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.