Clinical TrialJun 15, 2026, 08:02 AM
Legend Biotech's LB2501 Shows 100% ORR in B-NHL Trial
AI Summary
Legend Biotech announced positive first clinical proof-of-concept data for its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, LB2501, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The Phase 1 study showed a 100% objective response rate (ORR) and an 83.3% complete response rate (CR) at the higher dose level (DL2), with all responses ongoing. The therapy demonstrated a favorable safety profile with no dose-limiting toxicities, serious adverse events, or deaths reported. These results support the potential of LB2501 as a first-in-class therapy.
Key Highlights
- Legend Biotech's LB2501 achieved 100% ORR and 83.3% CR in relapsed/refractory B-NHL patients at dose level 2.
- LB2501 demonstrated dose-dependent in vivo CAR-T expansion without lymphodepletion in an ongoing Phase 1 study.
- No dose-limiting toxicities, serious adverse events, ICANS, or deaths were reported for LB2501.
- Infusion-related reactions and CRS were Grade 1-2 and did not require glucocorticoids for management.
- Translational data showed rapid vector clearance and polyclonal vector integration for LB2501.
- LB2501 is an investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy.
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