Clinical TrialJun 14, 2026, 03:16 AM
Legend Biotech LB2501 Phase 1 shows 100% ORR, 83.3% CR in B-NHL
AI Summary
Legend Biotech announced positive first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in a Phase 1 study for relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). At the higher dose level (DL2), LB2501 achieved a 100% objective response rate and an 83.3% complete response rate, with all responses ongoing. The therapy demonstrated a favorable safety profile with no dose-limiting toxicities or serious adverse events, and dose-dependent CAR-T expansion without lymphodepletion.
Key Highlights
- LB2501 achieved 100% objective response rate (ORR) and 83.3% complete response rate (CR) at dose level 2 (DL2) in R/R B-NHL patients.
- No dose-limiting toxicities, serious adverse events, ICANS, or deaths were reported in the study.
- Infusion-related reactions and cytokine release syndrome (CRS) were all Grade 1 2, with no glucocorticoids needed for CRS management.
- Dose-dependent in vivo CAR-T expansion was observed in 100% of patients at DL2 and 83% at DL1 without lymphodepletion.
- Overall ORR across both dose levels was 50.0% (6/12), and CR rate was 41.7% (5/12).
- Responses at DL2 were ongoing at the time of data cutoff.
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