Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465147
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
REACT-01 Reversing Autoimmunity Through Cell Therapy
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
REACT-01 Reversing Autoimmunity Through Cell Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 a phase 1 open-label non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus SLE to examine the safety feasibility and efficacy of administering T cell products derived from peripheral blood mononuclear cells PBMC that have been genetically modified to express CD19 specific chimeric antigen receptor CAR
A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells
A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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