The main purpse of this study is to evaluate the safety of KSD-101 in patients with EBV-associated Nasopharyngeal Carcinoma,to evaluate the initial clinical outcomes and evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated Nasopharyngeal Carcinoma.
Patients or their legal guardian voluntarily participate and sign an informed consent form.
Female or emale patients aged 18-70 years (inclusive of the cut-off value) on the date of signing the informed consent.
Nasopharyngeal carcinoma confirmed by pathological tissue examination and EBER-positive in tumor tissue by in situ hybridization (ISH or FISH).
Nasopharyngeal carcinoma with localized recurrence or localized recurrence with systemic metastasis, or primary metastatic nasopharyngeal carcinoma unsuitable for localized or radical treatment, for which there is no effective treatment and which is seriously life-threatening.
Patients receiving any anti-tumor therapy such as chemotherapy, radiotherapy, immunosuppressive therapy, etc. within 4 weeks prior to mono-collection.
Women who are pregnant (positive urine/blood pregnancy test), breastfeeding, or men or women who are planning to conceive within the last 1 year.
Active hepatitis B (HbsAg or HbcAb positive and HBV DNA ≥100 IU/mL), active hepatitis C (HCV antibody positive and peripheral blood HCV RNA positive); human immunodeficiency virus (HIV) antibody positive; syphilis test positive.
Patients with central nervous system pathology (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases).
Single group
KSD-101
Biological/VaccinePatients will receive approximately 5x10\^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
The incidence Adverse events (Safety endpoint)
Adverse events will be graded according to the NCI-CTCAE 5.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guidelines for Grading Criteria for Adverse Events in Clinical Trials of Vaccines for Prophylaxis.
EBV-DNA load
changes in EBV-DNA load were assessed during the study
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Duration of response (DOR)
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease
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