Leman Biotech announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for META 10-19, a metabolically armored CD19-targeted CAR-T cell therapy.
The IND clearance enables the initiation of U.S.-based clinical studies for patients with relapsed or refractory (R/R) CD19-positive B-cell hematologic malignancies. Targeted indications include B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL), such as diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).
