Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285279
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-22
Brief Title:
FKC288 in Participants With Autoimmune Kidney Diseases
Sponsor:
Nanjing University School of Medicine
Organization:
Nanjing University School of Medicine
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of FKC288 in Participants With Autoimmune Kidney Diseases A Single-center Exploratory Clinical Study
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 study is a single-center open-label dose-escalation exploratory clinical trial expected to enroll 6 to 12 participants It will use a BOIN Bayesian Optimal Interval design for dose escalation with four predetermined dose groups 03106 cellskg 10106 cellskg 30106 cellskg and an alternative dose of 01106 cellskg Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases such as lupus nephritis ANCA-associated vasculitis membranous nephropathy and IgG4-related diseases
Detailed Description:
A leukapheresis procedure will be performed to manufacture FKC288 chimeric antigen receptor CAR modified T cells Bridging therapy is allowed between PBMC collection and lymphodepletion Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days After 1-day rest subjects will receive a single dose infusion of FKC288 at 01 03 10 or 30x 106 CAR T cellsKg Subjects will be followed in the study for a minimum of 2 years after FKC288 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