Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553898
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Therapeutic Efficacy of Anti-B Cell Maturation AntigenBCMACluster of Differentiation 70CD70 CAR-T Cells in Patients With Multi-drug Resistant SRNS
Status:
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 investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMACD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS
Detailed Description:
At present there is no effective treatment for Multi-drug resistant nephrotic syndrome MDR-SRNS which has a high risk of progression to kidney failure and about 55 of patients will have disease recurrence after receiving kidney transplantation which is in urgent need of new treatment methods
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognitionSince 2019 CAR-T cell therapy has been successfully applied to autoimmune diseases Although no clinical data related to CAR-T treatment of nephrotic syndrome has been disclosed CAR-T is effective for systemic lupus erythematosus and systemic sclerosisMany kinds of autoimmune diseases such as chemical syndrome and idiopathic inflammatory dermatomyositis have good therapeutic effect These results suggest that the therapeutic effect of CAR T cells may not be limited to systemic lupus erythematosus but may also play a role in several different B-cell-mediated and autoantibody-driven human autoimmune diseases which is expected to bring breakthroughs in the treatment of MDR-SRNSThe purpose of this study is to assess the safety and efficacy of the anti-BCMACD70 CAR-T cells in the treatment of patients with MDR-SRNS
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognitionSince 2019 CAR-T cell therapy has been successfully applied to autoimmune diseases Although no clinical data related to CAR-T treatment of nephrotic syndrome has been disclosed CAR-T is effective for systemic lupus erythematosus and systemic sclerosisMany kinds of autoimmune diseases such as chemical syndrome and idiopathic inflammatory dermatomyositis have good therapeutic effect These results suggest that the therapeutic effect of CAR T cells may not be limited to systemic lupus erythematosus but may also play a role in several different B-cell-mediated and autoantibody-driven human autoimmune diseases which is expected to bring breakthroughs in the treatment of MDR-SRNSThe purpose of this study is to assess the safety and efficacy of the anti-BCMACD70 CAR-T cells in the treatment of patients with MDR-SRNS
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