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. 1. KSD-101 route of administration: subcutaneous injection. 2. KSD-101 treatment dose: 5.0 × 10\^6 cells/dose. 3. KSD-101 treatment frequency: once every 2 weeks for a total of 3-5 times. The 4th and 5th times are booster treatments, which need to be decided by the investigator according to the condition of the subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients 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.
Time frame: 1 year after DC Vaccines injection
EBV-DNA load
changes in EBV-DNA load were assessed during the study
Time frame: 1 year after DC Vaccines injection
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Time frame: 1 year after DC Vaccines injection
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 1 year after DC Vaccines injection
Levels of B cells
B cells in peripheral blood will be assessed to monitor changes
Time frame: 1 year after DC Vaccines injection
Levels of NK cells
NK cells in peripheral blood will be assessed to monitor changes
Time frame: 1 year after DC Vaccines injection
According to EORTC QLQ-C30
Changes of Quality of life, according to EORTC QLQ-C30
Time frame: Up to 1 year
According to EQ-5D-5L
Changes of Quality of life, according to EQ-5D-5L
Time frame: Up to 1 year
According to EORTC QLQ-H&N35
Changes of Quality of life, according to EORTC QLQ-H\&N35
Time frame: Up to 1 year
According to ECOG fitness status
Changes of Quality of life, according to ECOG fitness status
Time frame: Up to 1 year