NCT07529405

A Study of VG712 in Patients With Mycosis Fungoides

A Phase II Multi-center Randomized Clinical Trial to Determine the Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (VG712) in Subjects With Mycosis Fungoides (CurbMF Trial)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: Virogen Biotechnology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

VG712 (A-dmDT390-bisFv(UCHT1) fusion protein) is a recombinant anti-CD3 immunotoxin that selectively depletes CD3-positive T cells through irreversible inhibition of protein synthesis. This Phase II study (CurbMF-001) evaluates the safety and efficacy of VG712 compared with mogamulizumab in subjects with relapsed or refractory mycosis fungoides (MF) who have failed 2 or more prior systemic therapies. The study has two parts: a lead-in dosing part (BOIN design, up to 24 subjects) to determine RP2D, followed by a randomized part (approximately 322 subjects, 1:1 VG712 vs. mogamulizumab). Sponsor: Virogen Biotechnology Inc.

Detailed description

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.

Conditions

• Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	VG712	Recombinant anti-CD3 immunotoxin fusion protein composed of bivalent UCHT1 single-chain variable fragments linked to a modified diphtheria toxin (A-dmDT390). VG712 is administered intravenously to selectively deplete CD3-positive T cells.
DRUG	Mogamulizumab	Humanized monoclonal antibody targeting CCR4, administered intravenously for the treatment of T-cell lymphomas, including mycosis fungoides.

Timeline

• Start date: 2026-07-30
• Primary completion: 2030-12-30
• Completion: 2032-12-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study