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| Name | Class |
|---|---|
| Kousai Bio Co., Ltd. | OTHER |
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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.
Approximately 120 mL of PBMCs is collected from subjects. The collected PBMCs are transported to the manufacturing facility for the preparation of KSD-101. Subjects return to the study site for subsequent visits at investigator-notified times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSD-101 | Experimental | Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with EBV 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 |
|---|---|---|
| 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. | 1 year after DC Vaccines injection |
| Measure | Description | Time Frame |
|---|---|---|
| EBV-DNA load | 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 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 that has failed 3rd or more line treatment and has localized recurrence or localized recurrence with systemic metastasis or primary metastatic nasopharyngeal carcinoma that is not suitable for localized or radical treatment.
At least one measurable lesion according to RECIST v1.1 criteria.
An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
Have criteria for single or venous blood collection and have no other contraindications to cell collection.
Patients' laboratory findings are compatible:
Patients' corresponding lymph node region can accommodate subcutaneous injections.
Expected survival ≥ 3 months.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Han | Contact | 13822113698 | 86 | hanfei@sysucc.org.cn |
| Yali Quan | Contact | 15871707524 | 86 | quanyali@kousai.vip |
| Name | Affiliation | Role |
|---|---|---|
| Fei Han | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | 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 |