Legend Biotech shares first in vivo CAR-T data, its next act after Carvykti

Legend Biotech has for the first time released early human data from its in vivo CAR-T platform, represented by the investigational candidate LB2501, at the 2026 European Hematology Association (EHA) Congress.

LB2501 is a dual CD19/CD20‑targeting in vivo CAR-T therapy being evaluated in relapsed/refractory B‑cell non‑Hodgkin lymphoma (R/R B‑NHL).

In a Phase 1 dose‑escalation trial, 12 patients were treated across two dose cohorts; the higher dose cohort (DL2) showed a 100% objective response rate (ORR) and an 83.3% complete response (CR) rate with all responses still ongoing at the data cutoff.

The CAR-T cells expanded robustly in patients without the need for lymphodepleting chemotherapy, and CAR-T cells were detectable in peripheral blood for up to 116 days.

Safety was favorable:
no dose‑limiting toxicities, serious adverse events, or deaths were reported; infusion‑related reactions and cytokine release syndrome (CRS) occurred but were limited to Grade ≤2, and no immune effector cell‑associated neurotoxicity syndrome (ICANS) was observed.

These data position LB2501 as a potential first‑in‑class, off‑the‑shelf, single‑infusion in vivo CAR‑T for B‑cell malignancies and mark Legend’s next major strategic move beyond its approved multiple‑myeloma CAR‑T, CARVYKTI®.