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FDA clears IND for LB2501 in patients with R/R B-cell malignancies
On October 15, 2026, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for LB2501, an investigational, in vivo, CD19/CD20 dual-targeted chimeric antigen receptor (CAR) T-cell therapy, for the treatment of relapsed/refractory (R/R) B-cell malignancies, including B-cell non-Hodgkin lymphoma (NHL).1
The safety, tolerability, and preliminary efficacy of LB2501 is currently being investigated in an open-label, phase I study (NCT07002112) in patients with R/R B-cell malignancies in China, with initial results presented at the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE. A phase I/II study is planned to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of LB2501 in the U.S.1
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