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)
Virogen Biotechnology Inc.
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.
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 treatme…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and/or female, aged 18 years or older at the time of enrollment 2. Stage IB-IVB histologically confirmed relapsed or refractory mycosis fungoides (MF) without Sézary syndrome, with failure of 2 or more prior systemic therapies (for progression or toxicity as assessed by the investigator). Note: Total skin electron beam therapy, narrow band UVB, and psoralen plus UV light therapy are not counted as systemic therapies 3. ECOG performance status of 2 or less 4. Normal lung function evaluated by pulse oximetry after 5 minutes of rest in a seated position, with oxygen s…
Interventions
- DrugVG712
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.
- DrugMogamulizumab
Humanized monoclonal antibody targeting CCR4, administered intravenously for the treatment of T-cell lymphomas, including mycosis fungoides.
Location
- H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida