A Study of VG712 in Patients With Mycosis Fungoides (NCT07529405) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of VG712 in Patients With Mycosis Fungoides
United States386 participantsStarted 2026-07-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Adequate baseline organ function within 28 days before the start of study treatment, including: left ventricular ejection fraction (LVEF) of 50% or greater by MUGA scan or 2D echocardiogram without evidence of cardiac chamber hypertrophy, dilatation, or hypokinesis; no clinically significant abnormalities on a 12-lead ECG; bilirubin 1.5x ULN or less (except subjects with Gilbert's syndrome); AST and ALT each 2.5x ULN or less (or 5.0x ULN or less with known hepatic involvement by MF); calculated creatinine clearance greater than 50 mL/min using the Cockcroft-Gault formula; serum albumin 3.2 g/dL or greater (albumin infusions are not permitted to meet eligibility); platelets 75,000/uL or greater, ANC 1.0x10\^9/L or greater, Hgb greater than 8 g/dL (exception for subjects with low blood counts due to documented bone marrow involvement, with sponsor medical monitor approval required before enrollment)
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From randomization until disease progression or death, assessed up to 72 months post-EOT visit.
. Has recovered from toxicities (except alopecia) of prior chemotherapy or radiation therapy to Grade 1 or less according to NCI-CTCAE v5.0
✓. Females and males must be willing to use an approved form of contraception while on study drug and for 3 months after the last dose of study drug
✓. Expected survival of 3 months or greater
Exclusion criteria
✕. 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)
✕. History of active malignancy within 2 years, or malignancies that may interfere with data interpretation, other than nonmelanoma skin cancer, melanoma in situ, carcinoma in situ of the uterine cervix/prostate/bladder/breast, localized prostate cancer with PSA less than 0.1 ng/mL, or thyroid cancer
✕. Clinical evidence of central nervous system MF involvement
✕. Known active, uncontrolled autoimmune disease requiring systemic corticosteroids, cytotoxic or biologic therapy. Exceptions permitted include: type I diabetes mellitus; hypothyroidism only requiring hormone replacement therapy; skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic therapy
✕. Baseline corrected QT interval greater than 470 ms; baseline QT interval corrected with Fridericia's method (QTcF) greater than 470 ms (average of triplicate ECG)