Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 10:48 AM
Study NCT ID:
NCT06243159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JY231(Internal Clinical Drug Code) Injection for the Treatment of Refractory Autoimmune Diseases
Sponsor:
Shanxi Bethune Hospital
Organization:
Study Overview
Official Title:
JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
JY231、ADs
Brief Summary:
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases
Detailed Description:
This is a single-center, single-arm. open-treatment clinical study, in this study. approximately 10-20 adult and elderly patients with refractory autoimmune diseases will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects\' own previous standard treatment regimens or base data.
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?: