Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06010472
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-08-07
Brief Title:
An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus
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 CAR Nature Killer Cells KN5501 in the Treatment of Moderate to Severe Refractory Systemic Lupus Erythematosus SLE
Status:
RECRUITING
Status Verified Date:
2023-07
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-cluster of differentiation antigen 19 CD19 chimeric antigen receptor CAR natural killer NK cells KN5501 in patients with moderate to severe refractory systemic lupus erythematosus SLE 9-12 patients are planned to be enrolled in the dose-escalation trial The primary objective of the study was to evaluate the safety of allogeneic anti-CD19 CAR-NK cells KN5501 for the treatment of patients with moderate to severe refractory active SLE The secondary objective is to evaluate the efficacy of anti-CD19 CAR NK cells KN5501 in patients with moderate to severe refractory SLE including British Isles Lupus Assessment Group 2004 BILAG-2004 index Systemic Lupus Erythematosus Responder Index SRI-4 response rate Lupus Low Disease Activity State LLDAS rate and Definitions Of Remission In SLE DORIS remission rate
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