Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400303
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-08-29
Brief Title:
KYSA-5 A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell CD19 CAR T Therapy in Subjects With Systemic Sclerosis
Sponsor:
Kyverna Therapeutics
Organization:
Kyverna Therapeutics
Study Overview
Official Title:
KYSA-5 A Phase 12 Open-Label Multicentre Study of KYV 101 an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell CD19 CAR T Therapy in Subjects With Systemic Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-08
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 Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
Detailed Description:
SSc is an immune-mediated rheumatic disease that is characterized by fibrosis of the skin and internal organs and vasculopathy B-cells play a role in SSc and the disease is characterized by the presence of autoantibodies such as anti-Scl-70 and anti-RNAP III antibodies CD19-targeted chimeric antigen receptor CAR T-cells harness the ability of cytotoxic T-cells to directly and specifically lyse target cells to effectively deplete B-cells in the circulation and in lymphoid and potentially non-lymphoid tissues KYV-101 a fully human anti-CD19 CAR T-cell therapy will be investigated in adult subjects with systemic sclerosis
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