FDA Lifts Clinical Hold on Legend Biotech CAR T-Cell Therapy

The FDA has lifted its clinical hold on Legend Biotech’s investigational CAR-T cell therapy, LB1901.

LB1901, which targets malignant CD4+ T-cells, is intended for the treatment of adult patients with relapsed or refractory T-cell lymphoma.

The agency placed the clinical hold in February after a low CD4+ T-cell count was reported for the first patient dosed in the phase 1 study.

The FDA later told Legend that there was insufficient information in the Investigational New Drug application to assess the risks to subjects.