Cutaneous T Cell LymphomaPhase 1NCT05414500
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
A Phase 1 study testing Mogamulizumab and Brentuximab vedotin in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- What is being tested?
- Mogamulizumab and Brentuximab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and comply with study procedure, understand the risks involved in the study and provide written informed consent before the first study-specific procedure
- Men or women >18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides
- Must have CD30 positivity on recent biopsy of >1%
- Stage II-IV, for skin only disease >20% BSA should be involved, large cell transformation is allowed.
- Must have received at least one prior systemic therapy like bexarotene, interferons, ECP, methotrexate, Gemcitabine, Vorinostat etc. (patients who have received only skin directed therapy are not allowed)
- ECOG performance status of 0,1 or 2
Show all 20Show fewer
- Adequate organ function at screening defined as follows
- Hepatic: T bili <2 X ULN, isolated bilirubin of >2 is accepted if there is suspected diagnosis of Gilbert's syndrome, AST and ALT <3X ULN
- Renal: estimated GFR >40 mL/Min/1.73 m2
- Cardiac: LVEF >40%
- Patients must have completed any chemotherapy, radiation therapy, or biologic therapy specific to their neoplasm ≥ 1 weeks or 5 half-lives (whichever is longer). Radiation for palliation on symptomatic lesions has no wash out period.
- Expected life ≥ 4 months
- Participants with a prior history of stem cell transplant (autologous and/or allogeneic) are allowed if all of the following are met:
- 180 days or more have elapsed from the time of transplant
- subject has been off systemic immunosuppressive medications (including but not limited to: cyclosporine, tacrolimus, mycophenolate mofetil, or corticosteroids) for at least 30 days prior to C1D1. Topical steroids are permitted.
- no signs or symptoms of acute graft versus host disease, other than Grade 1 skin involvement.
- there are no signs or symptoms of chronic graft versus host disease
- requiring systemic therapy
- Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG], CTFG 2014) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. A woman is considered of childbearing potential (ie, fertile) following menarche and until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- Subjects and their partners with reproductive potential must agree to use 2 highly effective contraceptive measures during the study and must agree not to become pregnant or father a child for 3 months after the last dose of study treatment. Contraceptive measures that may be considered highly effective comprise combined hormonal contraception (oral, vaginal, or transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence, and surgically successful vasectomy. Abstinence is acceptable only if it is consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of birth control.
Who cannot join
- Prior exposure of BV < 6 months ago, or Moga. Prior exposure of BV is allowed if it is >6 months ago and CD30+ in >1% of in biopsy after last BV
- Active CNS involvement by MF/Sezary Syndrome
- Should not be receiving any other investigational agents. Prior use of investigational agents or other systemic therapy is allowed if it is >1 week ago or 5x half-life of the investigational agent whichever is shorter.
- Pregnant and lactating women
- Patients with clinically significant illness which would compromise participation in the study.
- Severe or uncontrolled systemic infection. (active skin infections in CTCL/MF patients are allowed once course of antibiotics is completed and infection is under control)
Show all 13Show fewer
- Known HIV infection
- Active Hepatitis B or C infection with active virus detected in blood. Hepatitis B core positive and HBsAg positivity are allowed if HBV DNA in blood is negative. Patient should be on antiviral prophylaxis. Hepatitis C positivity is allowed but HCV DNA by PCR must be negative in peripheral blood.
- Uncontrolled DM, HTN, NYHA Grade III-IV CHF, unstable angina, Myocardial infarction within past 3 months, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the investigator.
- Grade 2 or more peripheral sensory or motor neuropathy
- Prior severe allergic or anaphylactic reaction to monoclonal antibody or BV.
- History of solid organ transplant
- History of a second malignancy, excluding non-melanoma skin cell cancer within past 2 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Phase I Study of Mogamulizumab (M) in Combination With Brentuximab Vedotin (BV) in Previously Treated Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides (MF)
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
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Being tested
- Mogamulizumab, Brentuximab vedotin
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MogamulizumabDrug
Administered IV
Brentuximab vedotinDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Fixed dose of Mogamulizumab and dose de-escalation with Brentuximab Vedotin Receives: Drug: Mogamulizumab; Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Adverse Events
To determine safety, tolerability, and recommended dose of combination of Brentuximab Vedotin and Mogamulizmab in patients with Cutaneous T-Cell Lymphoma and Mycosis Fungoides.
Measured: through study completion, an average of 1 year
Rates of Serious Adverse Events
To determine safety, tolerability, and recommended dose of combination of Brentuximab Vedotin and Mogamulizmab in patients with Cutaneous T-Cell Lymphoma and Mycosis Fungoides.
Measured: At the end of cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
Duration of Response
To determine clinical benefit, Overall response rate and Duration of response
Measured: through study completion, an average of 1 year
Overall Response rate
To determine clinical benefit, Overall response rate and Duration of response
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Why it stopped: IRB audit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3 dose de-escalation design. Mogamulizumab at 1mg/kg and Brentuximab Vedotin at 3 different doses
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., Kyowa Kirin, Inc.
- Responsible party
- Principal investigator, Lauren Shea, University of Alabama at Birmingham
- Investigators
- Lauren Shea, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414500
- Sponsor's protocol ID
- IRB-300006649 (UAB2109)
- Other IDs
- 000535246, 000533654
- Status last verified
- Jun 2026
- First submitted
- 6 May 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Mogamulizumab (M) in Combination With Brentuximab Vedotin (BV) in Previously Treated Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides (MF)
- ClinicalTrials.gov ID
- NCT05414500
- Acronym / sponsor ID
- IRB-300006649 (UAB2109)
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: IRB audit
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Seagen Inc., Kyowa Kirin, Inc.
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose de-escalation design. Mogamulizumab at 1mg/kg and Brentuximab Vedotin at 3 different doses
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Drug: Mogamulizumab, Drug: Brentuximab vedotinFixed dose of Mogamulizumab and dose de-escalation with Brentuximab Vedotin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able to understand and comply with study procedure, understand the risks involved in the study and provide written informed consent before the first study-specific procedure
- Men or women >18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides
- Must have CD30 positivity on recent biopsy of >1%
- Stage II-IV, for skin only disease >20% BSA should be involved, large cell transformation is allowed.
- Must have received at least one prior systemic therapy like bexarotene, interferons, ECP, methotrexate, Gemcitabine, Vorinostat etc. (patients who have received only skin directed therapy are not allowed)
Key exclusion criteria (13 listed)
- Prior exposure of BV < 6 months ago, or Moga. Prior exposure of BV is allowed if it is >6 months ago and CD30+ in >1% of in biopsy after last BV
- Active CNS involvement by MF/Sezary Syndrome
- Should not be receiving any other investigational agents. Prior use of investigational agents or other systemic therapy is allowed if it is >1 week ago or 5x half-life of the investigational agent whichever is shorter.
- Pregnant and lactating women
- Patients with clinically significant illness which would compromise participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MogamulizumabAdministered IV | Drug | Cohort |
| Brentuximab vedotinAdministered IV | Drug | Cohort |
Primary outcome
Rates of Adverse Events
Time frame: through study completion, an average of 1 year
To determine safety, tolerability, and recommended dose of combination of Brentuximab Vedotin and Mogamulizmab in patients with Cutaneous T-Cell Lymphoma and Mycosis Fungoides.
Rates of Serious Adverse Events
Time frame: At the end of cycle 1 (each cycle is 28 days)
To determine safety, tolerability, and recommended dose of combination of Brentuximab Vedotin and Mogamulizmab in patients with Cutaneous T-Cell Lymphoma and Mycosis Fungoides.
2 secondary outcomes
Duration of Response
Time frame: through study completion, an average of 1 year
Overall Response rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cutaneous T Cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
Extracorporeal Photopheresis in Sezary Syndrome
Sezary Syndrome
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Shea, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mogamulizumab and Brentuximab vedotin in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Adverse Events (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.