Actively Recruiting
Phase I Study of Mogamulizumab in Combination With Brentuximab Vedotin in Previously Treated Cutaneous T Cell Lymphoma and Mycosis Fungoides
Led by University of Alabama at Birmingham · Updated on 2026-04-09
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, single-center, non-randomized phase I study to evaluate the safety and tolerability of combining Mogamulizumab and Brentuximab Vedotin in adults with previously treated Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides (MF). The study also aims to find a safe dose of this combination for future studies. Participants receive a fixed dose of Mogamulizumab intravenously along with a dose de-escalation of Brentuximab Vedotin administered intravenously. This dose adjustment helps determine the safest dose level for the combination. The study does not include a placebo group and involves only one study center. During the study, participants are closely monitored for adverse events and serious adverse events, particularly by the end of the first 28-day treatment cycle. Researchers will also assess the duration of treatment response and overall response rate over approximately one year. Safety and tolerability are the main focus, with participants undergoing regular evaluations throughout the study period.
CONDITIONS
Brief Title
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with study procedures and provide written informed consent
- Men or women older than 18 years with confirmed diagnosis of Sezary Syndrome or Mycosis Fungoides
- CD30 positivity over 1% on recent biopsy
- Stage II-IV disease, or skin-only disease involving more than 20% body surface area; large cell transformation allowed
- Received at least one prior systemic therapy (e.g., bexarotene, interferons, ECP, methotrexate, Gemcitabine, Vorinostat)
- ECOG performance status of 0, 1, or 2
- Adequate organ function including hepatic, renal, and cardiac parameters
- Completed prior chemotherapy, radiation, or biologic therapy at least 1 week or 5 half-lives before study start
- Expected life expectancy of at least 4 months
- For prior stem cell transplant recipients: at least 180 days since transplant, off systemic immunosuppressive medications for 30 days, no active graft versus host disease requiring systemic therapy
- Women of child-bearing potential must not be pregnant or breastfeeding and have a negative pregnancy test
- Participants and partners of reproductive potential must agree to use two effective contraceptive methods during the study and for 3 months after last dose
You will not qualify if you...
- Prior exposure to Brentuximab Vedotin within 6 months or Mogamulizumab
- Active central nervous system involvement by MF/Sezary Syndrome
- Receiving other investigational agents currently
- Pregnant or lactating women
- Clinically significant illness that compromises study participation
- Severe or uncontrolled systemic infection (controlled skin infections allowed)
- Known HIV infection
- Active Hepatitis B or C with detectable virus in blood; certain Hepatitis B or C statuses allowed with conditions
- Uncontrolled diabetes, hypertension, severe heart failure, unstable angina, recent heart attack, uncontrolled arrhythmia, or psychiatric/social issues limiting compliance
- Grade 2 or higher peripheral sensory or motor neuropathy
- History of severe allergic or anaphylactic reaction to monoclonal antibodies or Brentuximab Vedotin
- History of solid organ transplant
- History of second malignancy within past 2 years except non-melanoma skin cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Mogamulizumab and Brentuximab Vedotin administered intravenously in fixed and dose de-escalation schedules to treat their condition.
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
M
Margaret A Thomas, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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