Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400537
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-01
Brief Title:
Clinical Study of A-319 in the Treatment of ActiveRefractory Systemic Lupus Erythematosus
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Clinical Study of Recombinant CD19xCD3 Double Antibody A-319 in the Treatment of ActiveRefractory Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2024-10
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 purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody A-319 in activerefractory systemic lupus erythematosus SLE
Detailed Description:
The pathogenic B cells of patients with SLE can produce a large amount of autoantibodies which will form immune complexes and thereby inducing continuously expanding tissue damage and systemic inflammation A-319 is a kind of recombinant CD19xCD3 double antibody it can activate internal T cells to target and kill pathogenic B cells Clinical trials of A-319 are currently underway in hematological maliganancies concerning B cell abnormality Preclinical studies have shown the efficacy of A-319 in SLE The aim of this study is to investigate the safety tolerability pharmacokinetics PK pharmacodynamics PD immunogenicity and preliminary efficacy of A-319 in activerefractory SLE Patients with activerefractory SLE will be invited to participate in the study to receive A-319 intravenous infusion and follow-up visits of up to 1 years after enrollment
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