Phase 2 VG712 anti-CD3 immunotoxin (diphtheria toxin fusion) vs mogamulizumab in MF

Virogen Biotechnology’s CurbMF-001 is a Phase 2, multi-center study in relapsed/refractory mycosis fungoides (stage IB–IVB) after ≥2 prior systemic therapies, with a lead-in dose-finding component (BOIN design; up to 24 patients) followed by a randomized comparison (322 patients, 1:1). The investigational arm uses VG712 (A‑dmDT390‑bisFv[UCHT1]), a recombinant anti-CD3 immunotoxin that binds CD3-positive T cells and delivers a diphtheria-toxin catalytic domain that irreversibly blocks protein synthesis, aiming to deplete malignant/activated T cells. The control arm uses mogamulizumab (Poteligeo; Kyowa Kirin), a CCR4-directed monoclonal antibody commonly used in R/R MF/Sezary syndrome. Scientifically, this tests whether targeted T-cell depletion via an immunotoxin can compete with (or complement) the current antibody/immunotherapy approach in a setting where today’s care is sequential systemic therapy such as mogamulizumab, brentuximab vedotin for CD30+ disease, retinoids/interferon, HDAC inhibitors, methotrexate, and clinical trials, with skin-directed therapy layered when feasible. US multi-center (includes Tampa, FL; several additional US sites) | NCT07529405