VG712 for Mycosis Fungoides

(CurbMF Trial)

SC
HW
Overseen ByHerbert Wayne Hutman
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VG712 for individuals with relapsed or hard-to-treat mycosis fungoides, a type of skin lymphoma. The researchers aim to assess the safety and effectiveness of VG712 compared to the existing drug mogamulizumab. Participants will receive either VG712 or mogamulizumab. Those who have tried at least two other treatments without success and experience mycosis fungoides affecting their daily life might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have any therapy directed against your underlying cancer or investigational medications within 4 weeks of enrollment, and you should not use corticosteroids within 14 days before the first dose, except for certain conditions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested VG712, a new treatment for mycosis fungoides, for safety. Since this trial is in Phase 2, VG712 has already passed some basic safety tests in earlier trials. This phase focuses on finding the best dose and checking for side effects. VG712 remains under investigation, and more information is needed to fully understand its safety.

In contrast, mogamulizumab, another treatment option in the trial, has more safety information available. Research has shown that mogamulizumab works well and is generally safe for mycosis fungoides. Some patients have reported side effects, but these are often manageable.

Both treatments are under study to ensure they are safe and effective for people with mycosis fungoides. Prospective participants should discuss potential risks and benefits with a healthcare provider before joining the trial.12345

Why do researchers think this study treatment might be promising for mycosis fungoides?

Most treatments for mycosis fungoides, like phototherapy and topical steroids, focus on managing symptoms rather than changing the course of the disease. VG712 stands out because it is specifically designed to target the disease at a cellular level, potentially offering a more direct and effective approach. Unlike traditional treatments, VG712 is administered intravenously and works by targeting specific proteins involved in the progression of mycosis fungoides. This new mechanism of action could lead to better outcomes for patients by addressing the underlying cause of the disease rather than just alleviating symptoms. Researchers are excited because this could mean faster and more sustainable relief for patients.

What evidence suggests that this trial's treatments could be effective for mycosis fungoides?

Research has shown that VG712, a specially designed treatment, aims to help with mycosis fungoides by targeting and reducing harmful T cells. Although limited data exists on VG712's effectiveness in people, its mechanism appears promising. VG712 inhibits these T cells from producing proteins, potentially slowing the disease. This trial compares VG712 to another treatment, mogamulizumab, which demonstrated an average patient survival of 11.5 months. This comparison offers a reference point for evaluating VG712's effectiveness, as both treatments are tested in separate arms of the same study for this condition.12367

Are You a Good Fit for This Trial?

This trial is for adults (18+) with relapsed or hard-to-treat mycosis fungoides who have tried at least two previous systemic treatments. Participants must have good organ and lung function, not be pregnant or breastfeeding, and cannot join if they have certain heart, liver, or autoimmune conditions, recent cancers, severe allergies to study drugs, or active infections.

Inclusion Criteria

I am willing to use birth control during and for 3 months after the study drug.
I am able to care for myself and do light activities.
Expected survival of 3 months or greater
See 5 more

Exclusion Criteria

Severe allergic reactions to monoclonal antibodies or therapeutic proteins
I have moderate to severe liver cirrhosis.
Current evidence of large cell transformation (LCT) in the randomized part
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in Dosing

Lead-in dosing part uses a Bayesian Optimal Interval (BOIN) design to evaluate additional dose levels of VG712 in up to approximately 24 subjects to determine the recommended Phase 2 dose (RP2D).

4 consecutive days
Daily visits for 4 days

Randomized Treatment

Subjects are randomized to receive either VG712 at the RP2D or mogamulizumab according to the approved dosing regimen until disease progression or unacceptable toxicity.

Until disease progression or unacceptable toxicity
Multiple visits per cycle

Safety Follow-up

Participants are monitored for safety after treatment completion.

Up to 72 months post-EOT visit

Long-term Follow-up

Long-term follow-up to assess durability of response and long-term safety.

Up to 72 months post-EOT visit

What Are the Treatments Tested in This Trial?

Interventions

  • VG712

Trial Overview

The study compares a new drug called VG712 to an existing treatment called mogamulizumab in people with advanced mycosis fungoides. After an initial dose-finding phase, participants are randomly assigned to receive either VG712 or mogamulizumab to see which works better and is safer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: VG712 TreatmentExperimental Treatment1 Intervention
Group II: MogamulizumabActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virogen Biotechnology Inc.

Lead Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials
576
Recruited
145,000+

Citations

A Study of VG712 in Patients With Mycosis Fungoides

This Phase II study (CurbMF-001) evaluates the safety and efficacy of VG712 compared with mogamulizumab in subjects with relapsed or refractory mycosis ...

VG712 for Mycosis Fungoides (CurbMF Trial)

This Phase II study (CurbMF-001) evaluates the safety and efficacy of VG712 compared with mogamulizumab in subjects with relapsed or refractory ...

Efficacy and tolerability of mogamulizumab in mycosis ... - PMC

The observed median overall survival (OS) was 11.5 months, with 1 reported death due to septic shock in a patient who underwent salvage allo- ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41988991/

Real-World Outcomes of Mycosis Fungoides and Site ...

Patients with disease limited to the skin had 5- and 10-year OS rates of 86.1% and 78.0%, respectively. Nodal involvement at diagnosis was ...

Update on skin directed therapies in mycosis fungoides

In a review of patch and plaque stage MF patients treated nbUVB without systemic therapy, the CR rates were on average 84% (range =54% to 90%). Most received 3 ...

Top Mycosis Fungoides Clinical Trials | Power

VG712 for Mycosis Fungoides ... Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness.

Mycosis Fungoides Pipeline Insights Report 2025

The Mycosis Fungoides pipeline report provides detailed information of the Mycosis Fungoides pipeline products from the initial phase of product development ...