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A Study of VG712 in Patients With Mycosis Fungoides

ConditionMycosis Fungoides
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirogen Biotechnology Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and/or female, aged 18 years or older at the time of enrollment

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

ECOG performance status of 2 or less

Normal lung function evaluated by pulse oximetry after 5 minutes of rest in a seated position, with oxygen saturation values between 92% and 100% without supplemental oxygen

Disqualifiers

Current evidence of large cell transformation (LCT) in the randomized part (subjects with clinical features suggestive of LCT must have a biopsy performed within 4 months prior to Cycle 1 Day 1 without evidence of LCT; this exclusion criterion does not apply to the lead-in dosing part)

Inability to understand and give written informed consent for participation in this trial, including all evaluations and procedures specified by this protocol

Allergy to diphtheria toxin, a component of A-dmDT390-bisFv(UCHT1) fusion protein

Unstable or severe uncontrolled medical condition (e.g., uncontrolled diabetes, uncontrolled infections requiring systemic antibiotics, psychiatric illness/social situations, or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase risk to the subject)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: VG712 TreatmentExperimental treatment 1 intervention
Group B: MogamulizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to tumor progression or death from any cause, based on independent reviewer's assessment.

Time frame
From randomization until disease progression or death, assessed up to 72 months post-EOT visit.

Secondary outcomes

1

Overall Response Rate (ORR)

Proportion of subjects achieving CR or PR per investigator's and independent reviewer's assessment using consensus criteria at each scheduled assessment.

Time frame
Up to 72 months post-EOT visit.
2

Duration of Response (DOR)

Time from first documented response (CR or PR) to disease progression or death from any cause, assessed by investigator and independent reviewer per consensus criteria.

Time frame
Up to 72 months post-EOT visit.
3

Incidence of adverse events (AEs)

Incidence of adverse events (AEs) graded per NCI-CTCAE version 5.0, including treatment-related AEs, serious adverse events (SAEs), and AEs leading to study drug discontinuation.

Time frame
Up to 72 months post-EOT visit.
4

Overall Survival (OS)

Time from randomization to death from any cause (key secondary endpoint). OS rate assessed at 1 year and annually thereafter.

Time frame
Up to 72 months post-EOT visit.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virogen Biotechnology Inc.

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: