eligibility_summary
Adults 18–70 with EBER+ nasopharyngeal carcinoma after ≥3 prior lines, measurable disease, recurrent/metastatic not eligible for radical therapy. ECOG 0–1, adequate blood counts, liver/renal/cardiac (LVEF ≥40%) and coagulation, fit for blood collection, injectable lymph node site, life expectancy ≥3 months. Excludes recent therapy/vaccines/trials/surgery, pregnancy, active HBV/HCV/HIV/TB, CNS disease, serious comorbidity, other cancers, severe allergy, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: KSD-101, an autologous dendritic cell (DC) vaccine (biologic cell therapy). Patient PBMCs are used to generate monocyte-derived DCs ex vivo, pulsed with Epstein–Barr virus (EBV) antigens, and administered subcutaneously (5×10^6 cells/dose, every 2 weeks, 3–5 doses). Mechanism: DCs present EBV peptides on MHC I/II to prime and expand EBV-specific CD8+ cytotoxic and CD4+ helper T cells, boosting antitumor immunity in EBV+ nasopharyngeal carcinoma. Targets/pathways: dendritic cell antigen presentation, T-cell activation (TCR recognition, cross-presentation), Th1/CTL responses, ultimate target is EBV-expressing NPC tumor cells. Aim: safety, preliminary efficacy, immune response.