eligibility_summary
Eligibility: Chinese adults (≥18) with histologically confirmed MF/SS, stages IB–IV, after ≥1 prior systemic therapy, ECOG ≤1, prior AEs ≤Grade 1, adequate marrow, liver, renal function, negative pregnancy test and effective contraception. Exclude current large-cell transformation, CNS metastases, major/uncontrolled illness, HIV/HBV/HCV, active herpes, autoimmune disease, mAb allergy, pregnancy/lactation, prior mogamulizumab, recent therapy, transplants, or immunomodulators.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06285370: Open-label, single-arm Phase 4 trial in China testing mogamulizumab (KW‑0761), a humanized, defucosylated IgG1 monoclonal antibody immunotherapy targeting CCR4, in previously treated mycosis fungoides or Sézary syndrome. Mechanism: binds CCR4 on malignant skin-homing T cells and regulatory T cells (Tregs), blocks CCR4–chemokine (CCL17/TARC, CCL22/MDC) signaling, and drives potent antibody‑dependent cellular cytotoxicity (ADCC) via NK cells to deplete CCR4+ cells. Targets/pathways: CCR4+ Sézary/MF tumor T cells (often Th2‑skewed), CCR4+ Tregs, the CCR4 chemokine axis, and FcγRIIIa‑mediated ADCC, aiming to reduce tumor burden and relieve Treg‑mediated immunosuppression.