A Study of VG712 in Patients With Mycosis Fungoides

Mycosis fungoides (MF) is the most common subtype of primary cutaneous T-cell lymphoma (CTCL). Patients with advanced or relapsed/refractory MF often experience disease progression despite available systemic therapies, including mogamulizumab, and have limited durable treatment responses, representing a significant unmet medical need.

VG712 is a recombinant anti-CD3 immunotoxin designed to selectively deplete CD3-positive T cells. By targeting the CD3 receptor, VG712 induces rapid and transient T-cell depletion, with subsequent recovery of the T-cell population following completion of treatment. This mechanism may enable elimination of pathogenic or malignant T cells while allowing immune reconstitution.

This study (CurbMF-001) is a Phase II study evaluating the safety and efficacy of VG712 compared with mogamulizumab in subjects with relapsed or refractory MF who have received two or more prior systemic therapies.

The study consists of two sequential parts. The lead-in dosing part uses a Bayesian Optimal Interval (BOIN) design to evaluate additional dose levels of VG712 in up to approximately 24 subjects at a single site to determine the recommended Phase 2 dose (RP2D).

The randomized part will enroll approximately 322 subjects at multiple centers. Subjects will be randomized in a 1:1 ratio to receive either VG712 at the RP2D or mogamulizumab according to the approved dosing regimen. Treatment will continue until disease progression or unacceptable toxicity.

Both parts of the study include a screening period, treatment period, safety follow-up, and long-term follow-up to assess durability of response and long-term safety.