Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373081
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Anti-CD19-CD3E-CAR-T Cells in RelapsedRefractory Autoimmune Disease
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
A Clinical Study on the Safety and Efficacy of Anti-CD19-CD3E-CAR-T Cells in the Treatment of Relapsed or Refractory Autoimmune Disease
Status:
RECRUITING
Status Verified Date:
2024-04
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 is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases
Detailed Description:
This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases
Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Interim analysis will be performed when participants finish the visit of 12 weeks after CAR-T cells infusion
Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Interim analysis will be performed when participants finish the visit of 12 weeks after CAR-T cells infusion
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?:
None