Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides

NCT05414500 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: IRB-300006649 (UAB2109)000535246000533654
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mycosis Fungoides; Cutaneous T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the end of cycle 1 (each cycle is 28 days)

Secondary Outcomes (2)

• Duration of Response

  through study completion, an average of 1 year

• Overall Response rate

  through study completion, an average of 1 year

Study Arms (1)

Cohort

EXPERIMENTAL

Fixed dose of Mogamulizumab and dose de-escalation with Brentuximab Vedotin

Drug: Mogamulizumab; Drug: Brentuximab vedotin

Interventions

Mogamulizumab DRUG

Administered IV

Cohort

Brentuximab vedotin DRUG

Administered IV

Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Seagen Inc.: collaborator
• Kyowa Kirin, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Interventions

mogamulizumab; Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Amit Mehta, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret A Thomas, MPH

CONTACT

205-895-1802; margaretannthomas@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 3+3 dose de-escalation design. Mogamulizumab at 1mg/kg and Brentuximab Vedotin at 3 different doses

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: June 10, 2022
• Study Start: May 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)