Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469190
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-17
Brief Title:
An Exploratory Clinical Study of Anti-CD19 CAR NK Cell KN5501 in the Treatment of RelapsedRefractory Immune Nephropathy
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor NK Cell Injections KN5501 in the Treatment of RelapsedRefractory Immune Nephropathy
Status:
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 anti-CD19 CAR NK cell injection KN5501 in patients with immune nephropathy 36 patients are planned to be enrolled in the dose-escalation trial The primary endpoints are DLT and TEAEs The secondary endpoints are the overall response rates ORR and disease control rate DCR
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