Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316076
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-12
Brief Title:
Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
A Clinical Study for the Safety and Efficacy of CD19-CAR-DNT Cells RJMty19 in the Treatment of Relapsed or Refractory Autoimmune Diseases
Status:
RECRUITING
Status Verified Date:
2024-03
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:
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsedrefractory autoimmune diseases
Detailed Description:
This is an open single-arm single-dose dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose of CD19-CAR-DNT cells the safety the preliminary efficacy and the pharmacokinetic profile of CD19-CAR-DNT cells in patients after infusion 8-24 patients are planned to be enrolled in the dose-escalation trial and 12-24 patients in the dose-expansion trial The primary endpoints are DLT MTD and the incidence of abnormalities in AESAEAESIlaboratory test
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