FDA Halts Legend Biotech’s CAR-T Cell Therapy Trial After Just One Patient is Dosed

After dosing just one patient in a phase 1 trial, the FDA put a clinical hold on Legend Biotech’s early-stage CAR-T cell therapy, LB1901, which targets malignant CD4+ T-cells.

The company has paused the trial being conducted at the University of Texas MD Anderson Cancer Center in Houston due to low CD4+ T-cell counts in the patient’s peripheral blood and notified the FDA. Legend added that the patient, who began receiving the treatment in September, has not experienced drug-related serious adverse events and is being monitored closely.

The trial was designed to enroll 50 patients with CD4+ relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma to tease out the safety and tolerability of the drug while finding a dose for phase 2, said the company.