Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370026
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-14
Brief Title:
KSD-101 Therapy for Standard Treatment Failed EBV-associated NPC an Exploratory Clinical Trial
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma an Exploratory Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpse of this study is to evaluate the safety of KSD-101 in patients with EBV-associated Nasopharyngeal Carcinomato 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 50 106 cellsdose
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
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 50 106 cellsdose
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None