Clinical TrialJun 2, 2026, 09:36 AM
Legend Biotech: LB2501 Shows 100% ORR in Phase 1 NHL Trial
AI Summary
Legend Biotech announced promising preliminary clinical data for its investigational in vivo CAR-T cell therapy, LB2501, for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The data, to be presented at EHA 2026, showed a 100% objective response rate (ORR) and 83.3% complete response rate (CR) in the dose level 2 cohort. The therapy demonstrated a favorable safety profile with no DLTs, SAEs, or ICANS, and showed robust in vivo CAR-T expansion.
Key Highlights
- LB2501 Phase 1 trial in R/R B-NHL showed 100% ORR and 83.3% CR at dose level 2 (n=6).
- No dose-limiting toxicities (DLTs), serious adverse events (SAEs), or deaths observed.
- Cytokine release syndrome (CRS) occurred in 66.7% of patients, all Grade 2 or lower.
- No immune effector cell-associated neurotoxicity syndrome (ICANS) reported.
- Dose-dependent in vivo CAR-T expansion observed, with cells detectable up to 116 days.
- LB2501 is an investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy.
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