NCT06097793

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Kousai Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	KSD-101	Patients will receive approximately 5x10\^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-10-24
• Last updated: 2024-03-12

Locations

1 site across 1 country: China