Legend Biotech reports first clinical proof‑of‑concept data for LB2501, an in vivo CD19/CD20 dual‑targeting CAR‑T, in relapsed/refractory B‑cell non‑Hodgkin lymphoma, presented in a late‑breaking session at EHA 2026.

The late‑breaking EHA 2026 presentation (Abstract LB5006) underscores Legend Biotech’s leadership in next‑generation cell therapies beyond CARVYKTI.

In the Phase 1 dose‑escalation, a single LB2501 infusion at the higher DL2 achieved a 100% objective response rate (6/6) and 83.3% complete responses (5/6), with all responses ongoing at data cutoff.

LB2501 showed dose‑dependent in vivo CAR‑T expansion without lymphodepletion, and safety was favorable with no dose‑limiting toxicities, serious adverse events, ICANS, or deaths; any infusion reactions and CRS were Grade 1–2 and did not require steroids.

Translational analyses demonstrated polyclonal, diverse vector integrations and no evidence of non‑specific transduction in off‑target populations, supporting feasibility of in vivo T‑cell engineering.

A senior researcher emphasized in vivo CAR‑T as a frontier in cell therapy, with LB2501 potentially simplifying treatment and expanding access, building on CARVYKTI’s foundation.

Pharmacokinetics showed detectable CAR‑T cells for up to about four months, with 100% expansion at DL2 and 83% at DL1; vector clearance was rapid, with viral copies peaking immediately after infusion and becoming undetectable within 24 hours.

The study enrolled 12 patients across two dose levels (6 per level), with a median of three prior therapies and 58.3% refractory to the most recent treatment, aiming to assess safety, determine a recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B‑NHL.

Across both dose levels, the overall ORR was 50% and the CR rate was 41.7%, with all DL2 responses ongoing at data cutoff and including DLBCL, MCL, and FL patients.

Additional translational data highlighted rapid vector clearance and non‑specific transduction absence, reinforcing the feasibility of in vivo CAR‑T strategies.