Legend Biotech presents first-in-human Phase 1 data for LB2501 in vivo CAR-T therapy at EHA 2026

Legend Biotech Corporation announced preliminary clinical data for its investigational LB2501 therapy. The data will be presented during a late-breaking session at the European Hematology Association 2026 Congress in Stockholm, Sweden. The Phase 1 study evaluated LB2501 in 12 patients with relapsed or refractory B-cell non-Hodgkin lymphoma across two dose levels. At dose level 2, the objective response rate reached 100 percent in six patients, including a complete response rate of 83.3 percent. All responses were ongoing at data cutoff as of April 1, 2026. CAR-T cells showed dose-dependent expansion and remained detectable in peripheral blood for up to 116 days. The therapy generated these cells directly in patients after a single infusion without requiring cell manufacturing or lymphodepleting chemotherapy. No dose-limiting toxicities, serious adverse events, or deaths were reported. Infusion-related reactions occurred in 75 percent of patients, all Grade 2 or lower. Cytokine release syndrome affected 66.7 percent of patients but stayed at Grade 2 or lower, and no immune effector cell-associated neurotoxicity syndrome occurred. LB2501 is a CD19/CD20 dual-targeting in vivo CAR-T therapy built on the TaVec platform. It is under evaluation in an ongoing Phase 1, open-label study for safety, tolerability, and preliminary efficacy in patients with relapsed or refractory B-cell malignancies.