Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy
Key Highlights
- ➤FDA clears LB2501 IND for relapsed/refractory B-cell malignancies
- ➤Planned U.S. Phase 1/2 study will assess safety and preliminary efficacy
- ➤Single-infusion, off-the-shelf therapy generates dual-targeting CD19/CD20 CAR-T cells in patients
- ➤LB2501 is first known dual-targeting in vivo CAR-T therapy with FDA IND clearance
- ➤China Phase 1 study is ongoing in relapsed/refractory B-cell malignancies
Expert Statements
Ingrid Zhang, Chief Executive Officer of Legend Biotech
“We believe in vivo CAR-T represents the next frontier of cell therapy, with the potential to bring transformative, life-changing treatments to many more patients around the world.”
Ingrid Zhang, Chief Executive Officer of Legend Biotech
“The FDA’s clearance of our IND application marks an important step in advancing LB2501 and our broader in vivo cell engineering platform.”
Ingrid Zhang, Chief Executive Officer of Legend Biotech
“Building on Legend’s deep CAR-T experience, we are working to develop an approach that could help simplify access to and delivery of this important treatment class.”
* 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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