Who is eligible for clinical trial NCT07529405?

Participants must meet the protocol's inclusion criteria for Mycosis Fungoides. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07529405 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-07

A Study of VG712 in Patients With Mycosis Fungoides (NCT07529405)

A Phase II Multi-center Randomized Clinical Trial to Determine the Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (VG712) in Subjects With Mycosis Fungoides (CurbMF Trial)

🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Virogen Biotechnology Inc.

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (15 items).

Location: H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)
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

Usually NOT eligible if any of the following apply:

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)
Poorly controlled hypertension defined as systolic BP greater than 160 mmHg or diastolic BP greater than 90 mmHg on 2 consecutive measurements separated by 1 week despite 2 antihypertensive medications. Subjects receiving a beta blocker for hypertension must be converted to another antihypertensive drug class (angiotensin inhibitors, angiotensin receptor blockers, or calcium channel blockers are all acceptable) at least 2 weeks before receiving study drug
History of or currently active cardiovascular disease within 12 months before the first dose of study drug, including: myocardial infarction or coronary artery bypass grafting, cardiomyopathy, unstable angina pectoris, clinically significant cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), or cerebrovascular accident. Atrial fibrillation is allowed if rate is controlled (resting heart rate less than 90 bpm and less than 180 bpm during exercise)
Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the investigator would put the subject at significant risk for pulmonary complications during the study

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida

📞 Contact the Study Coordinator

Phone: (925) 699-2195

Email: chensu@virogenbio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Mycosis Fungoides

ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome — Duarte, California
Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome — Basking Ridge, New Jersey
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides — Chicago, Illinois
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients — Stanford, California
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides — Houston, Texas

Explore by condition: All Mycosis Fungoides clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗