Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 6:04 PM
Study NCT ID:
NCT07059169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-T Therapy for Refractory Autoimmune Diseases
Sponsor:
LiangZou
Organization:
Study Overview
Official Title:
An Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of Targeted Cluster of Differentiation 19 (CD19) CAR-T Therapy for Refractory Autoimmune Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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 study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases.
Detailed Description:
This open-label, single-arm study aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases. The study includes two pretreatment regimens: lymphodepletion and non-lymphodepletion.
Under the lymphodepletion regimen, after enrollment, patients will undergo leukapheresis followed by 3-5 days of fludarabine and cyclophosphamide lymphodepletion therapy. Subsequently, JY231 injection (CAR-T cell therapy) and autologous Peripheral blood mononuclear cell(PBMC) will be concurrently administered via double-lumen catheter intravenous infusion.
The non-lymphodepletion regimen involves direct infusion of JY231 injection without prior lymphodepletion.
Following infusion, subjects will undergo safety and efficacy assessments for up to 24 months to determine whether disease control is achieved.
Under the lymphodepletion regimen, after enrollment, patients will undergo leukapheresis followed by 3-5 days of fludarabine and cyclophosphamide lymphodepletion therapy. Subsequently, JY231 injection (CAR-T cell therapy) and autologous Peripheral blood mononuclear cell(PBMC) will be concurrently administered via double-lumen catheter intravenous infusion.
The non-lymphodepletion regimen involves direct infusion of JY231 injection without prior lymphodepletion.
Following infusion, subjects will undergo safety and efficacy assessments for up to 24 months to determine whether disease control is achieved.
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?: