eligibility_summary
Include: adults 18–70 with EBV‑associated hematologic neoplasm refractory/relapsed or choosing DC vaccine, ECOG 0–1, eligible for apheresis/IV collection, adequate hematologic, hepatic, renal, cardiac (LVEF ≥40%), and coagulation function, injectable lymph node. Exclude: recent anticancer therapy (<1 mo), pregnancy/plan conception, active HBV/HCV/HIV/syphilis, CNS disorder, uncontrolled infection, serious comorbidities, other cancers <3 yrs, live vaccines or trials <4 wks, severe drug allergy (incl penicillin), drug abuse, investigator decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05635591 tests KSD-101, an autologous monocyte-derived dendritic cell (DC) vaccine pulsed with Epstein–Barr virus (EBV) antigens. Drug type: cellular immunotherapy/biologic. Mechanism: ex vivo–generated DCs present EBV peptides on MHC I/II to prime and expand EBV-specific CD8+ cytotoxic and CD4+ helper T cells, promoting a Th1-skewed response and immune memory, leading to targeted lysis of EBV-infected malignant cells. Targets: dendritic cell antigen presentation pathways, T-cell priming/activation via TCR recognition of EBV antigens, effector CTL-mediated killing of EBV+ hematologic tumor cells. Phase 1, single-arm, subcutaneous dosing bi-weekly for 3–5 doses, primary focus on safety, DLTs, and MTD in EBV-associated hematologic neoplasms.