eligibility_summary
Adults with MF stage IB–IIB (never ≥IIIA), relapsed/refractory after ≥1 systemic therapy, WHO PS 0–1, adequate marrow/organ and cardiac function. Anti‑CD4/alemtuzumab allowed after ≥3 mo washout (CD4≥200). Exclude: prior mogamulizumab/anti‑CCR4 or TSEB, recent RT/systemic therapy, other cancer <5y (exceptions), severe mAb/CHO allergy, uncontrolled illness/cardiac, active zoster, HTLV‑1/HIV, active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Open-label, phase II, single-arm trial in stage IB–IIB cutaneous T‑cell lymphoma testing: 1) Mogamulizumab—humanized, defucosylated anti‑CCR4 IgG1 monoclonal antibody (immunotherapy). Mechanism: binds CCR4 on malignant T cells and CCR4+ regulatory T cells, enhancing ADCC (and complement-mediated killing) to deplete CCR4+ cells for systemic control and immune modulation, 2) Total Skin Electron Beam therapy (TSEB)—skin-directed electron radiation. Mechanism: delivers superficial electrons to induce DNA damage/apoptosis in cutaneous lymphoma lesions. Targets/pathways: CCR4 chemokine receptor on malignant CTCL cells and Tregs (tumor microenvironment), reducing CCR4-driven trafficking/survival, radiation targets skin-resident lymphoma via DNA damage response. Sequence: mogamulizumab induction → low-dose TSEB (12 Gy/8 fractions) → mogamulizumab maintenance.