eligibility_summary
Eligible: adults (≥18) with relapsed/refractory MF (stage IB–IV) or Sézary syndrome starting single-agent mogamulizumab, consented, willing to undergo baseline/indicative biopsies for mogamulizumab-associated rash and provide blood at baseline and at rash onset if applicable. Exclude: concurrent systemic or skin-directed CTCL therapies (except topical steroids) and prior mogamulizumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Standard-of-care mogamulizumab, a humanized, defucosylated IgG1 monoclonal antibody that targets CCR4. Mechanism of action: binds CCR4 on malignant cutaneous T cells (common in mycosis fungoides and Sézary syndrome) and on regulatory T cells, enhancing NK cell–mediated ADCC via Fcγ receptors, depleting CCR4+ cells, and modulating the CCR4/CCL17/CCL22 chemokine axis to shift the immune milieu. Study design: prospective, observational, no experimental therapy—patients already receiving mogamulizumab undergo skin exams/photos, biopsies, and blood sampling to assess mogamulizumab-associated rash (MAR), differentiate MAR from disease progression, and relate MAR to treatment response. Targets/pathways: CCR4-expressing malignant T cells and Tregs, NK cell ADCC pathway, skin immune microenvironment.