Phase II VT-EBV-201 trial: VT-EBV-N for EBV-positive ENKTL

Results from the randomized, double-blind, placebo-controlled, multicenter, phase II VT-EBV-201 trial (NCT03671850), evaluating VT-EBV-N, an autologous Epstein–Barr virus (EBV)-specific cytotoxic T-lymphocyte (CTL) therapy, as post-remission therapy in patients with EBV-positive extranodal natural killer/T-cell lymphoma (ENKTL; N = 48), were presented by Deok-Hwan Yang at the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE. Patients were randomized 1:1 to receive VT-EBV-N (n = 21) or autologous peripheral blood mononuclear cells (PBMCs; n = 25). The primary endpoint was 2-year disease-free survival (DFS).

Key data: The 2-year DFS rate was 95.0% with VT-EBV-N (95% confidence interval [CI], 69.5–99.3) vs 77.6% with PBMC control (95% CI, 54.2–90.0), and the 4-year DFS rate was 95.0% with VT-EBV-N (95% CI, 69.5–99.3) vs 56.3% with PMBCs (95% CI, 31.0–75.4) (hazard ratio [HR], 0.13; 95% CI, 0.02–1.02; p = 0.021). The overall survival (OS) rates were 100% with VT-EBV-N at 2- and 4-years vs 88.0% (95% CI, 67.3–96.0) and 83.8% (95% CI, 62.4–93.6) with PBMCs, respectively (p = 0.0205). Grade ≥3 adverse events (AEs) occurred in 10% vs 16% of patients receiving VT-EBV-N vs PBMCs; serious AEs (SAEs) occurred in 19% vs 28%. No Grade ≥3 adverse drug reactions (ADRs) or serious ADRs occurred with VT-EBV-N.

Key learning: VT-EBV-N demonstrated durable post-remission disease control with a manageable safety profile in patients with EBV-positive ENKTL, supporting further evaluation as a potential consolidation strategy.