Legend Biotech Establishes Clinical Proof-of-Concept for LB2501 in Relapsed/Refractory B‑Cell Non‑Hodgkin Lymphoma

Legend Biotech announced first clinical proof-of-concept data for LB2501, a new in vivo CD19/CD20 dual-targeting CAR-T therapy, in patients with relapsed or refractory B‑cell non‑Hodgkin lymphoma (R/R B‑NHL). In a Phase 1 study, a single infusion of LB2501 produced dose‑dependent in vivo CAR‑T expansion without lymphodepletion, with a 100% objective response rate (6/6) and 83.3% complete response rate (5/6) at the higher dose. The therapy showed a favorable safety profile, with no dose‑limiting toxicities, serious adverse events, immune effector cell‑associated neurotoxicity syndrome, or deaths reported. LB2501 is an investigational, potential first‑in‑class in vivo CAR‑T designed to generate CAR‑T cells directly in the patient after a single IV infusion and is being evaluated in an ongoing Phase 1 study (NCT07002112) for safety, tolerability, and preliminary efficacy in relapsed/refractory B‑cell malignancies.