Legend Biotech’s LB2501 CAR-T Hits 100% ORR and 83% CR
LEGN•Legend Biotech’s Phase 1 study of LB2501 in relapsed/refractory B-NHL reported a 100% ORR (6/6) and 83.3% CR (5/6) at dose level 2 in an off-the-shelf, single-infusion in vivo CAR-T therapy. No DLTs, SAEs, or ICANS occurred, and CAR-T cells persisted up to 116 days without lymphodepletion.
1. Phase 1 LB2501 Trial Data
In an ongoing Phase 1 open-label study (NCT07002112) of LB2501 for relapsed/refractory B-cell non-Hodgkin lymphoma, 12 patients across two dose levels have been treated. At dose level 2, six patients achieved a 100% objective response rate and an 83.3% complete response rate with responses ongoing at data cutoff. Dose-dependent in vivo CAR-T expansion was observed, and engineered CAR-T cells were detected in peripheral blood for up to 116 days.
2. Safety Profile and Upcoming Presentation
No dose-limiting toxicities, serious adverse events or immune effector cell-associated neurotoxicity were observed; infusion reactions in 75% and grade ≤2 CRS in 66.7% of patients were reported. These findings will be featured in a late-breaking oral session (Abstract #LB5006, Session s204) at the EHA 2026 Congress in Stockholm on June 14, highlighting potential for simplified, off-the-shelf CAR-T delivery and broader patient access.
