LB2501

Oct. 15, 2026: Legend Biotech (NASDAQ: LEGN) announced FDA clearance of the IND for LB2501, an investigational off-the-shelf in vivo CAR-T therapy for relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma. LB2501 is designed to generate dual-targeting CD19/CD20 CAR-T cells directly in patients after a single infusion and, according to the company, is the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance.

The IND clearance supports a planned U.S. Phase 1/2 study that will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy. The therapy is being evaluated without lymphodepleting chemotherapy. LB2501 uses Legend’s TaVec platform and a replication-incompetent lentiviral vector designed to selectively transduce T cells.

The release also notes an ongoing Phase 1 open-label study in China (NCT07002112) in patients with relapsed or refractory B-cell malignancies assessing safety, tolerability, and preliminary efficacy. No clinical efficacy or safety results were reported in this announcement.