Actively Recruiting
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
Led by University of Alabama at Birmingham · Updated on 2026-04-09
10
Participants Needed
1
Research Sites
169 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
This is an open label, single center, non-randomized dose de-escalation phase I study of combination of BV and Mogamulizumab. The primary objective of the study is to assess the safety and tolerability of the combination. The primary objective is also to explore safe dose of combination for future expansion.
CONDITIONS
Official 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 over 18 years old with confirmed Sezary Syndrome or Mycosis Fungoides
- CD30 positivity of more than 1% on recent biopsy
- Stage II-IV disease with more than 20% body surface area involved if skin-only disease; 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 criteria
- Completed prior chemotherapy, radiation, or biologic therapy at least 1 week or 5 half-lives before starting
- Expected life expectancy of at least 4 months
- If prior stem cell transplant, at least 180 days have passed and 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
- Agreement to use two highly 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 exposure
- Active central nervous system involvement by MF or Sezary Syndrome
- Receiving other investigational agents currently
- Pregnant or lactating women
- Clinically significant illness that could interfere with study participation
- Severe or uncontrolled systemic infections; controlled skin infections allowed after antibiotics
- Known HIV infection
- Active Hepatitis B or C with detectable virus; controlled Hepatitis B or C allowed with specific conditions
- Uncontrolled diabetes, hypertension, severe heart conditions, recent heart attack, unstable angina, uncontrolled arrhythmia, or serious psychiatric illness
- Peripheral sensory or motor neuropathy grade 2 or higher
- History of severe allergic or anaphylactic reaction to monoclonal antibodies or Brentuximab Vedotin
- History of solid organ transplant
- History of a second malignancy except non-melanoma skin cancer within past 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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