Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy
The FDA cleared Legend Biotech's IND application for LB2501, an investigational in vivo CAR-T therapy targeting CD19/CD20 for relapsed or refractory B-cell malignancies including B-cell non-Hodgkin lymphoma. LB2501 is an off-the-shelf, single-infusion therapy designed to generate CAR-T cells directly within the patient, and is the first known dual-targeting in vivo CAR-T to receive IND clearance; a planned U.S. Phase 1/2 study will assess safety, tolerability, pharmacokinetics, and preliminary efficacy, and a Phase 1 study is ongoing in China (NCT07002112).
Key figures
- Drug Name
- LB2501
- Phase Of Trial
- Phase 1/2
- Targets
- CD19/CD20
- Indication
- relapsed or refractory B-cell malignancies including B-cell non-Hodgkin lymphoma
- First of kind
- first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance
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