eligibility_summary
Adults 18–70 with EBER+ nasopharyngeal carcinoma that’s recurrent/metastatic and not suitable for curative local therapy, ≥1 RECIST-measurable lesion, ECOG 0–1, adequate blood, liver, renal, cardiac, coagulation, eligible for cell collection and nodal SC injection. Exclude recent therapy, pregnancy/plans, active HBV/HCV/HIV/syphilis, CNS disease, active infection/TB, serious comorbidities/other cancers, recent surgery/live vaccine/other trial, severe or penicillin allergy, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
KSD-101 is an autologous dendritic cell (DC) vaccine (cellular immunotherapy/biologic) made from a patient’s peripheral blood monocytes differentiated into DCs and pulsed with multiple EBV antigens. Mechanism: antigen-loaded DCs present EBV tumor antigens via MHC I/II to prime and expand EBV-specific CD8+ cytotoxic T cells and CD4+ helper T cells, promoting a Th1/IFN-gamma–biased anti-tumor response against EBV-positive nasopharyngeal carcinoma. Targets: ex vivo–generated dendritic cells (as the product), T-cell activation pathways (TCR–MHC signaling, antigen presentation), and EBV antigen–expressing NPC tumor cells as CTL targets. Dosing: 5×10^6 cells subcutaneously every 2 weeks for 3–5 doses (boosters as needed). Early-phase, single-arm exploratory trial assessing safety, preliminary efficacy, and immune responses.