Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

manilatimes.net · 2026-10-15

LB2501 is an off-the-shelf in vivo CAR-T therapy designed to generate dual-targeting CD19/CD20 CAR-T cells directly within the patient after a single infusion, making it the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance IND clearance supports planned U.S. Phase 1/2 study and advances Legend Biotech’s in vivo cell engineering platform BRIDGEWATER, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting chimeric antigen receptor T (CAR-T) cells directly within the patient, for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.

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