Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150651
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-11-13
Brief Title:
Safety of PiggyBac Transposon CAR T-cells Targeting CD-19 in Refractory Lupus
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
SafetyPhase I Study of PiggyBac Transposon Mediated Chimeric Antigen Receptor T Cells Targeting CD-19 in Thai Patients With Refractory Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2024-02
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:
A Phase 1 clinical trial to evaluate the safety and efficacy of PiggyBac transposon-mediated Chimeric Antigen ReceptorCAR T-cells targeting CD19 in refractory Systemic Lupus Erythematosus SLE patients who have not responded to standard immunosuppressive treatments
Detailed Description:
This is a single-institution phase I study in adults with refractory SLE Autologous Peripheral Blood Mononuclear Cells will be transduced with a chimeric antigen receptor targeting the B-cell surface antigen CD19 using the PiggyBac Transposon system Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide followed by the infusion of 1x106 cellskg CD-19 CAR T-cells Subjects will be evaluated post-treatment for toxicity SLE disease activity and the persistence of CAR-expressing T cells in vivo
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