eligibility_summary
Eligibility: Adults 18–70 with EBV‑associated lymphoma refractory/relapsed or choosing DC vaccine, ECOG 0–1, eligible for apheresis/IV collection, adequate blood, liver, renal, cardiac (LVEF ≥40) and coagulation function, injectable lymph node, consent. Exclude: recent anticancer therapy, pregnancy/trying, HBV/HCV/HIV/syphilis, CNS disease, uncontrolled infection, serious comorbidities, other active cancers, recent live vaccine/trial, severe drug allergy, substance abuse, investigator veto.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: KSD-101, an autologous monocyte-derived dendritic cell (DC) vaccine pulsed with EBV-associated antigens (biological immunotherapy). Mechanism: ex vivo–generated DCs present EBV antigens via MHC I/II to prime and expand EBV-specific T-cell responses—activating CD8+ cytotoxic T cells and CD4+ helper T cells, enhancing TCR signaling, IFN-γ production, and perforin/granzyme-mediated tumor cell killing. Targets: EBV-infected lymphoma cells (e.g., B-cell or NK/T-cell lymphomas) expressing latent viral antigens (e.g., LMP1, LMP2, EBNA), pathways include antigen presentation and adaptive immune activation. Dosing: ~2.5–10×10^6 DCs subcutaneously every 2 weeks for 3–5 doses. Study: Early Phase 1, single-arm, primary aim is tolerability/DLT and dose range. Status: Withdrawn (no participants).