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. 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
12
Patients will receive approximately 5x10\^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
RECRUITINGSafety 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.
Time frame: 1 year after DC Vaccines injection
EBV-DNA load
Antiviral effect: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival (OS)
OS is measured from the date of the initial injection of DC Vaccines to the date of the participant's death
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