Legend Biotech gets FDA IND clearance for in vivo CAR-T candidate LB2501

On October 15, 2026, Legend Biotech Corporation announced that the U.S. Food and Drug Administration cleared its investigational new drug application for LB2501, an in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting chimeric antigen receptor T cells directly within the patient, for use in relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.¹

The company said the planned U.S. Phase 1/2 study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of LB2501.¹ Legend Biotech described the clearance as making LB2501 the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance.¹

The therapy is built to work without separate manufacturing of patient-derived cells outside the body; instead, it uses a single infusion to produce CAR-T cells inside the patient, and the company noted the therapy is being evaluated without lymphodepleting chemotherapy.¹

On the science, Legend Biotech said LB2501 is built on its proprietary TaVec platform and uses an engineered, replication-incompetent lentiviral vector designed to selectively transduce T cells, which then generate a chimeric antigen receptor targeting both CD19 and CD20.¹ The company said targeting both antigens is meant to counter resistance mechanisms such as antigen escape in B-cell cancers.

LB2501 already has clinical experience outside the U.S.: a trial titled "The CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies" (NCT07002112) is running in China as an open-label Phase 1 study assessing safety, tolerability, and preliminary efficacy.

Legend Biotech, which also develops and markets CARVYKTI with collaborator Johnson & Johnson, called the IND clearance a step forward in its broader in vivo cell engineering platform, according to CEO Ingrid Zhang.