Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT06097793
Brief 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
Detailed 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:
NCT06097793
Study Brief:
Protocol Section:
NCT06097793