LB2501 (In Vivo CAR-T)

June 02, 2026 — Legend Biotech USA Inc. announced that initial Phase 1 data from its investigational in vivo CAR-T candidate LB2501 (CD19/CD20 dual-targeting) in relapsed/refractory B‑cell non-Hodgkin lymphoma (R/R B‑NHL) will be presented as a late-breaking oral at the European Hematology Association (EHA) 2026 Congress (Abstract #LB5006; June 14, 2026, Stockholm).

In an ongoing Phase 1 open-label study (NCT07002112), 12 R/R B‑NHL patients were treated across two dose levels. As of April 1, 2026, efficacy at dose level 2 (median follow-up 2.2 months) showed an objective response rate of 100% (6/6) and complete response rate of 83.3% (5/6), with all responses ongoing at cutoff. Pharmacokinetics showed dose-dependent in vivo CAR-T expansion, with CAR-T cells detectable in blood up to 116 days.

Safety findings included no dose-limiting toxicities, serious adverse events, or deaths; infusion-related reactions (75%) and cytokine release syndrome (66.7%) were all ≤ grade 2, and no ICANS was reported. Clinically, the data support potential feasibility of a single-infusion, off-the-shelf in vivo CAR-T approach without lymphodepleting chemotherapy.