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Brief Title: KSD-101 Therapy for Standard Treatment Failed EBV-associated NPC: an Exploratory Clinical Trial
Official Title: KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
Study ID: NCT06370026
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. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Name: Fei Han
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR