Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337474
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-19
Brief Title:
An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia
Sponsor:
Changzhou No2 Peoples Hospital
Organization:
Changzhou No2 Peoples Hospital
Study Overview
Official Title:
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections for the Treatment of Refractory Primary Immune Thrombocytopenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
A single arm open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells KN5501 in patients with refractory immune thrombocytopenia 9 patients are planned to be enrolled in the dose-escalation trial 9109 cells 135109 cells The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsedrefractory B-cell related autoimmune diseases The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia The exploratory objective is to evaluate expansion persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None