A Study of VG712 in Patients With Mycosis Fungoides

Part of paid clinical trials in Tampa, Florida.

Sponsor
Virogen Biotechnology Inc.
Study ID
NCT07529405
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Mycosis Fungoides

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VG712 — DRUG
    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.
  • Mogamulizumab — DRUG
    Humanized monoclonal antibody targeting CCR4, administered intravenously for the treatment of T-cell lymphomas, including mycosis fungoides.

Study Details

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.

Key Dates

Start date
Jul 30, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2030
Completion
Dec 30, 2032

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VG712 Treatment
    Lead-in dosing part: VG712 administered IV (twice daily, 4-6 hours apart, for 4 consecutive days) at escalating total doses of 5, 10, 15, or 20 ug/kg per the BOIN design. Randomized part Arm 1: VG712 at RP2D administered IV (twice daily x 4 consecutive days; each injection equals 1/8 of the total RP2D).
  • Active Comparator: Mogamulizumab
    Mogamulizumab was administered at a dose of 1.0 mg/kg as an intravenous infusion over at least 60 minutes on Days 1, 8, 15, and 22 of Cycle 1, and on Days 1 and 15 of each subsequent 28-day cycle, until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From randomization until disease progression or death, assessed up to 72 months post-EOT visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612
Yumeng Zhang, MD
[email protected]
(813) - 745-2191
Yumeng Zhang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

Related Studies