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KSD-101 Therapy for EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial

Nasopharyngeal Carcinoma Clinical Trial

Official title:
KSD-101 Therapy for EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06097793
Study type Interventional
Source Kousai Bio Co., Ltd.
Contact Guangyuan Hu
Phone +86 13886000095
Email h.g.y.121@163.com
Status Recruiting
Phase Early Phase 1
Start date December 4, 2023
Completion date December 31, 2025
View Details
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