Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464679
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of RelapsedRefractory Autoimmune Diseases
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injection for the Treatment of RelapsedRefractory Autoimmune Diseases
Status:
RECRUITING
Status Verified Date:
2024-06
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 in patients with autoimmune diseases 36-72 patients are planned to be enrolled in the dose-escalation trial The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases
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