The FDA cleared an investigational new drug application for LB1901, a chimeric antigen receptor T-cell therapy in development for treatment of adults with relapsed or refractory T-cell lymphoma, according to the agent’s manufacturer.

LB1901 (Legend Biotech) is an autologous CAR T-cell therapy that targets the CD4 protein on the surface of cancer cells.

The IND clearance will allow Legend Biotech to begin a first-in-human, phase 1 study of LB1901. The multicenter open-label study will enroll patients with relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma.

The trial will assess the safety and tolerability of LB1901. Researchers also will determine the recommended dose for a phase 2 study.

T-cell lymphoma accounts for less than 15% of non-Hodgkin lymphoma cases in the United States.

Peripheral T-cell lymphoma is rare and often aggressive, with an estimated 39% of patients surviving 5 years. A substantial percentage of patients with peripheral T-cell lymphoma and cutaneous T-cell lymphoma — which primarily occur in the skin — relapse after treatment with available therapies.

“The FDA’s clearance of Legend’s IND application for LB1901 is a milestone representative of the company’s scientific expertise in cell therapy innovation,” Ying Huang, PhD, CEO and chief financial officer of Legend Biotech, said in company-issued press release. “We look forward to working with the investigators as we explore its potential in meeting the great unmet medical needs in the [T-cell lymphoma] population.”

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