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FDA clears Legend Biotech's IND for LB2501, an in vivo CAR-T therapy for B-cell malignancies
LEGNLegend Biotech Corp
The U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy developed by Legend Biotech Corporation. This clearance supports a planned U.S. Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the off-the-shelf single-infusion treatment for relapsed or refractory B-cell malignancies, including non-Hodgkin lymphoma. LB2501 is built on Legend’s proprietary TaVec platform and aims to generate dual-targeting CAR-T cells directly within patients without lymphodepleting chemotherapy. The company operates in the biotechnology sector, specializing in cell therapy innovations such as its marketed product CARVYKTI.