Ignite Creation Date:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06548620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of RD06-04 in Patients With Active Autoimmune Diseases
Sponsor:
Nanjing Bioheng Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CD19-targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases Mediated by Autoantibodies.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. The study population includes patients with Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis (MG).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: