Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548620
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study of RD06-04 in Patients With Active Autoimmune Diseases
Sponsor:
None
Organization:
None
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:
No
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 Sjögrens Syndrome SS Multiple Sclerosis MS Neuromyelitis Optica Spectrum Disorder NMOSD and Myasthenia Gravis MG
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None