BRIDGEWATER, N.J., October 15, 2026

Legend Biotech Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LB2501, an investigational in vivo chimeric antigen receptor T-cell (CAR-T) therapy designed to generate CD19/CD20 dual-targeting CAR-T cells directly inside the patient. The therapy is being developed for relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma (B-NHL). The regulatory clearance supports plans for a U.S. Phase 1/2 clinical study assessing safety, tolerability, pharmacokinetics and preliminary efficacy. The announcement also advances Legend Biotech’s strategy to develop next-generation cell therapies through its proprietary in vivo cell-engineering platform.

LB2501 Designed to Simplify CAR-T Treatment Delivery

LB2501 is being developed as an off-the-shelf, single-infusion therapy that aims to generate CAR-T cells within the patient rather than relying on the multiple manufacturing steps associated with conventional autologous CAR-T treatments. The investigational approach is also being evaluated without lymphodepleting chemotherapy, a preparatory treatment used in certain conventional CAR-T regimens. According to Legend Biotech, these design features could potentially simplify treatment delivery and broaden access to cell therapy. The planned U.S. study will investigate the candidate’s safety profile, tolerability, pharmacokinetic characteristics and preliminary signs of therapeutic activity. Although the FDA’s IND clearance allows the development program to proceed in the United States, it does not establish the therapy’s safety or efficacy, and LB2501 remains investigational.

TaVec Platform Enables Dual CD19/CD20 Targeting

LB2501 is built on Legend Biotech’s proprietary TaVec™ platform and uses an engineered, replication-incompetent lentiviral vector designed to selectively transduce T cells. Following transduction, the modified T cells are intended to generate a chimeric antigen receptor that recognizes both CD19 and CD20, two targets associated with B-cell malignancies. The dual-targeting strategy is designed to address potential antigen escape, a mechanism in which cancer cells may evade treatment by reducing or losing expression of a targeted antigen. By targeting two antigens, LB2501 aims to address this potential resistance pathway, although clinical studies will be needed to determine whether the approach provides meaningful benefits for patients. Legend Biotech described the FDA clearance as an important milestone for LB2501 and its broader in vivo cell-engineering platform..

Advertisement

cGxPJobs Banner

Development Advances for Relapsed or Refractory B-Cell Cancers

The planned U.S. Phase 1/2 study will evaluate LB2501 in patients with relapsed or refractory B-cell malignancies, a population that can face limited treatment options after multiple lines of therapy. B-cell non-Hodgkin lymphoma represents a diverse group of cancers arising from B lymphocytes, and treatment outcomes vary across disease subtypes and individual patients. Legend Biotech also reports that LB2501 is being evaluated in an ongoing Phase 1, open-label study in China, registered under NCT07002112, involving patients with relapsed or refractory B-cell malignancies. That study is assessing safety, tolerability and preliminary efficacy. The U.S. IND clearance marks a step toward expanding the clinical development program geographically. Future clinical evidence will be required to establish LB2501’s risk-benefit profile, determine the durability of any responses and assess its potential role among existing treatment approaches.

Source:::Legend Biotech press release