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

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

Treatments tested in this trial

VG712
Mogamulizumab

Treatment groups

386 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Virogen Biotechnology Inc.

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Source ClinicalTrials.gov