FDA clears investigational new drug application for CAR T-cell therapy, LB1901, for relapsed/refractory T-cell lymphoma

On December 14, 2020, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug application for LB1901, an autologous chimeric antigen receptor (CAR) T-cell therapy that targets CD4, which is expressed in most T-cell lymphoma subtypes.

A first-in-human clinical trial of LB1901 will now be initiated in the U.S. for patients with relapsed/refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma. The primary objectives of the phase I study are to evaluate the safety and tolerability of LB1901 and to establish the recommended phase II dose.

This decision represents a positive step forward for patients with relapsed/refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma, for whom there is a significant unmet medical need.