Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:42 AM
Study NCT ID:
NCT07347860
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of (A-319) in the Treatment of Active Rheumatoid Arthritis
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) in the Treatment of Active Rheumatoid Arthritis
Status:
RECRUITING
Status Verified Date:
2026-01
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 primary objective of the study was to evaluate the safety and tolerability of A-319 in patients with active rheumatoid arthritis.
Detailed Description:
Active rheumatoid arthritis (RA) is an autoimmune disease characterized by erosive arthritis as its primary clinical manifestation. A-319 is a recombinant CD19xCD3 bispecific antibody that activates T cells in vivo and targets and kills pathogenic B cells. A-319 is currently in clinical trials for B-cell hematologic malignancies. Preclinical results in animal models of systemic lupus erythematosus (SLE) and RA have also demonstrated that A-319 can alleviate or eliminate autoimmune disease-related symptoms and progression by depleting pathogenic B cells in individuals with autoimmune diseases. This investigator-initiated trial (IIT) evaluated the safety, tolerability, pharmacokinetic profile, biological markers, and preliminary efficacy of A-319 in the treatment of patients with rheumatoid arthritis (RA) who have refractory responses to at least two different therapies with different mechanisms of action.
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?: