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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides

Phase I Study of Mogamulizumab (M) in Combination With Brentuximab Vedotin (BV) in Previously Treated Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides (MF)

Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides (NCT05414500) is a Phase 1 interventional studying Cutaneous T Cell Lymphoma and Mycosis Fungoides, sponsored by University of Alabama at Birmingham. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Cutaneous T Cell Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to understand and comply with study procedure, understand the risks involved in the study and provide written willing to sign a consent form before the first study-specific procedure 2. Men or women \>18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides 3. Must have CD30 positivity on recent biopsy of \>1% 4. Stage II-IV, for skin only disease \>20% BSA should be involved, large cell transformation is allowed. 5. Must have received at least one previous cancer treatment that works throughout the body (like chemotherapy) like bexarotene, interferons, ECP, methotrexate, Gemcitabine, Vorinostat etc. (patients who have received only skin directed therapy are not allowed) 6. You should be able to carry out daily activities with 0 level of ability (ECOG 0),1 or 2 7. your organs (liver, kidneys, etc.) are working well enough based on blood tests 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% 8. 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. 9. Expected life ≥ 4 months 10. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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 2. Men or women \>18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides 3. Must have CD30 positivity on recent biopsy of \>1% 4. Stage II-IV, for skin only disease \>20% BSA should be involved, large cell transformation is allowed. 5. 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) 6. ECOG performance status of 0,1 or 2 7. 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% 8. 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. 9. Expected life ≥ 4 months 10. 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 11. 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. 12. 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. Exclusion Criteria: 1. 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 2. Active CNS involvement by MF/Sezary Syndrome 3. 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. 4. Pregnant and lactating women 5. Patients with clinically significant illness which would compromise participation in the study. 6. 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) 7. Known HIV infection 8. 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. 9. 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. 10. Grade 2 or more peripheral sensory or motor neuropathy 11. Prior severe allergic or anaphylactic reaction to monoclonal antibody or BV. 12. History of solid organ transplant 13. History of a second malignancy, excluding non-melanoma skin cell cancer within past 2 years.

Treatments Being Tested

DRUG

Mogamulizumab

Administered IV

DRUG

Brentuximab vedotin

Administered IV

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Alabama at Birmingham
Birmingham, Alabama, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05414500), the sponsor (University of Alabama at Birmingham), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05414500 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05414500?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05414500?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05414500. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05414500. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.