eligibility_summary
Adults (≥18) with ECOG ≤1, biopsy-proven CTCL (MF/SS) stage IIB–IVB, measurable unirradiated disease (mSWAT), failed ≥1 systemic therapy, adequate organ function, archival tissue or biopsy, life expectancy ≥6 mo, ≤10 mg prednisone ok, CNS disease allowed, consent/contraception required. Exclude: HIV, active HBV/HCV, prior PD-1 or mogamulizumab, recent RT, high-dose immunosuppression, significant autoimmune/ILD, other active cancers, infection, prior allo or solid organ transplant, pregnancy/breastfeeding, severe allergy to study drugs, recent investigational drugs/live vaccines, conditions impairing participation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm study in advanced-stage relapsed/refractory cutaneous T‑cell lymphoma (mycosis fungoides/Sézary). Interventions: Pembrolizumab (Keytruda), a humanized IgG4 monoclonal antibody checkpoint inhibitor targeting PD‑1, blocks PD‑1/PD‑L1/PD‑L2 to restore/exhaustion-reverse effector T‑cell activity. Mogamulizumab (Poteligeo), a defucosylated humanized IgG1 monoclonal antibody against CCR4, induces ADCC to deplete CCR4+ malignant T cells and regulatory T cells (Tregs). Targets/pathways: PD‑1 checkpoint on T cells (enhances anti-tumor immunity), CCR4 on skin-homing malignant T cells and Tregs, impacting the CCL17/CCL22 axis and reducing immunosuppression. Rationale: combine immune activation with tumor/Treg depletion.