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KSD-101 Therapy for Standard Treatment Failed EBV-associated NPC: an Exploratory Clinical Trial

Nasopharyngeal Carcinoma Clinical Trial

Official title:
KSD-101 Therapy for Standard Treatment Failed 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. 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06370026
Study type Interventional
Source Sun Yat-sen University
Contact Fei Han
Phone 13822113698
Email hanfei@sysucc.org.cn
Status Not yet recruiting
Phase Early Phase 1
Start date May 1, 2024
Completion date December 31, 2026
View Details
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