Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Stages IB-IV MF or SS
• Stages IB-IV MF or SS
• At least 1 prior standard-of-care therapy
• Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities
• ≥ 18 years of age
• ECOG performance status of 0 to 2
• All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v 5.0).
• MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue.
• The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable.
• ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer/CTCL therapies
• ≥ 2 weeks for phototherapy, local radiation therapy
• ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
• ≥ 12 weeks for total skin electron beam therapy
• > 12 weeks for alemtuzumab
• Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director.
• Adequate hematologic function
• Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3)
• Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
• Adequate hepatic function
• Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
• Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
• Adequate renal function
• Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula.
• If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test.
• WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
• Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.

You cannot join if

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• MF with limited disease (Stage IA) or central nervous system (CNS) disease
• Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 2 weeks prior to 1st day of treatment)
• Pregnant or breastfeeding
• Active autoimmune disease or history deemed by the investigator to be clinically significant
• Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.
• Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the Screening Visit, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

mogamulizumab-kpkc. A humanized monoclonal antibody directed against C-C chemokine receptor 4 (CCR4) with potential anti-inflammatory and antineoplastic activities. Mogamulizumab selectively binds to and blocks the activity of CCR4, which may inhibit CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, and chemokine-mediated angiogenesis. In addition, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells. CCR4, a G-coupled-protein receptor for C-C chemokines such MIP-1, RANTES, TARC and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and some types of neurons. CCR4, also known as CD194, may be overexpressed on adult T-cell lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) cells. NCI Drug Dictionary

Treatments listed in the registry

• Mogamulizumab (Drug): Administered 1 mg/kg as an intravenous infusion over at least 60 minutes on Days 1, 8, 15, and 22 of the first 28 day cycle and on Days 1 and 15 of each subsequent cycle.
• LD TSEBT (Radiation): Patients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks

Na · Single Group · masking: None

Main goals

• Overall response rate (ORR) (12 months)

Other goals

• Time-to-Next Significant Treatment (TTNT)
• Progression free survival (PFS)
• Duration of response (DOR)
• Patient reported Quality of Life (QoL)
• Treatment-related Adverse Events ≥ Grade 3
• Proportion of Participants With ≥4, ≥6, and ≥12 Months of Response Duration (ORR4, ORR6, and ORR12)

Planned enrollment: 30 (estimated).

• Stanford Cancer Center, Stanford, California

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT04256018
• NCI Drug Dictionary: C62510

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 30, 2026. Public record; not medical advice.