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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
This is a single-center, single-arm, open, multiple-dose clinical study,evaluating the safety, preliminary efficacy, and immune response of KSD-101 for the treatment of patients with EBV-associated nasopharyngeal carcinoma.
Enrolled subjects will receive a peripheral blood single nucleated cell collection (D-20) of approximately 120-150 ml. After the single collection is transported to the dendritic cell vaccine preparation party via the cold chain, a dendritic cell vaccine (KSD-101) will be prepared using the subject's own single nucleated cells. After successful preparation of KSD-101, the subject will return to the hospital for KSD-101 reinfusion as follows.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSD-101 | Experimental | Biological: Dendritic Cell Vaccine(Autologous monocyte-derived DCs pulsed with EBV Multi-antigen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSD-101 | Biological | Patients will receive approximately 5x10^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. Monitor and assess the incidence and relevance to study drug and severity of all adverse events, vital signs, physical examination and laboratory findings. | 1 year after DC Vaccines injection |
| Measure | Description | Time Frame |
|---|---|---|
| EBV-DNA load | Antiviral effect: changes in EBV-DNA load were assessed during the study | 1 year after DC Vaccines injection |
| Objective response rate (ORR) | The percentage of participants who achieved PR or better response |
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Inclusion Criteria:
Patients or their legal guardians voluntarily participate and sign the informed consent form.
male or female 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.
at least one measurable lesion according to RECIST v1.1 criteria.
have an Eastern Cooperative Oncology Group (ECOG) score: 0-1.
have criteria for single or venous blood collection and have no other contraindications to cell collection.
the patient's laboratory findings are compatible:
The patient's corresponding lymph node region can meet the demand for subcutaneous injection.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangyuan Hu | Contact | +86 13886000095 | h.g.y.121@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guangyuan Hu | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | 430030 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 1 year after DC Vaccines injection |
| Disease control rate (DCR) | The percentage of participants who achieved SD or better response | 1 year after DC Vaccines injection |
| 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 | 1 year after DC Vaccines injection |
| Progression-free survival (PFS) | The time from the start of CAR-GPRC5D treatment for the participants to the first time of disease progression or death for any reason | 1 year after DC Vaccines injection |
| Overall survival (OS) | OS is measured from the date of the initial injection of DC Vaccines to the date of the participant's death | 1 year after DC Vaccines injection |
| Levels of EBV-specific CD8+ T cells | EBV-specific CD8+ T cells in peripheral blood will be assessed to monitor changes | 1 year after DC Vaccines injection |
| Levels of B cells | B cells in peripheral blood will be assessed to monitor changes | 1 year after DC Vaccines injection |
| Levels of NK cells | NK cells in peripheral blood will be assessed to monitor changes | 1 year after DC Vaccines injection |
| According to EORTC QLQ-C30 | Changes of Quality of life, according to EORTC QLQ-C30 | Up to 1 year |
| According to EQ-5D-5L | Changes of Quality of life, according to EQ-5D-5L | Up to 1 year |
| According to EORTC QLQ-H&N35 | Changes of Quality of life, according to EORTC QLQ-H&N35 | Up to 1 year |
| According to ECOG fitness status | Changes of Quality of life, according to ECOG fitness status | Up to 1 year |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |