Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:36 AM
Study NCT ID:
NCT07490951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cluster of Differentiation 19 (CD19)/B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases
Sponsor:
Shenzhen Genocury Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
A Clinical Study on the Safety, Tolerability and Preliminary Efficacy of Targeted CD19/BCMA CAR-T Therapy in the Treatment of Refractory Autoimmune Diseases (ADs)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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/BCMA CAR-T in the treatment of refractory autoimmune diseases.
Detailed Description:
This open-label, single-arm clinical trial aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases.
No lymphodepletion conditioning regimen will be administered in this study. The lentiviral vector drug of CD19/BCMA-targeted CAR-T therapy will be infused directly.
Following infusion, subjects will undergo safety and efficacy assessments for up to 24 months to determine whether disease control is achieved.
No lymphodepletion conditioning regimen will be administered in this study. The lentiviral vector drug of CD19/BCMA-targeted CAR-T therapy will be infused directly.
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:
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?: