eligibility_summary
Eligibility: Screening (US): adults >=18 with consent. Treatment: anti-HTLV-1+, PVL >=8%, >=18, stable labs (ANC >=1000, Plt >=100k, Hgb >=9, AST/ALT/Cr/Tbili <=1.5x ULN, SpO2 >=90%), ECG ok, contraception as needed. Exclude: recent immunosuppressants/IFN-alpha (<6 mo), serious comorbidity, active autoimmune (recent tx), ATL, pregnancy/lactation, TB, MI <12 mo, antibody-drug allergy, active HBV/HCV/HIV (unless controlled), recent study drugs/supplements, spinal cord compression, uncontrolled psych/neuro, or PI decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 prevention study in high‑risk HTLV‑1 carriers tests mogamulizumab (KW‑0761), a humanized, afucosylated IgG1 monoclonal antibody immunotherapy targeting CCR4. Arms: Cohort 1—0.3 mg/kg every 12 weeks (2 doses), Cohort 2—0.3 mg/kg every 6 weeks (4 doses). Mechanism: binds CCR4 on CD4+ T cells (including HTLV‑1–infected/ATL‑prone clones and regulatory T cells) and induces antibody‑dependent cellular cytotoxicity via NK‑cell Fcγ receptors, depleting CCR4+ cells, interferes with the CCR4–CCL17/CCL22 chemokine axis. Targets: CCR4+ T cells (Tregs, Th2/activated CD4+ subsets), HTLV‑1–infected CCR4+ clones, and the ADCC pathway (FcγRIIIa on NK cells).