Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342960
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-27
Brief Title:
KYSA-3 A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell CD19 CAR T Therapy in Subjects With Refractory Lupus Nephritis
Sponsor:
Kyverna Therapeutics
Organization:
Kyverna Therapeutics
Study Overview
Official Title:
KYSA-3 A Phase 12 Open-Label Multicenter Study of KYV-101 an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell CD19 CAR T Therapy in Subjects With Refractory Lupus Nephritis
Status:
RECRUITING
Status Verified Date:
2024-09
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 Refractory Lupus Nephritis
Detailed Description:
Systemic lupus erythematosus SLE is a chronic autoimmune disease characterized by a wide spectrum of organ involvement and disease severity Renal involvement categorized as lupus nephritis LN may occur in approximately 50 of SLE patients and is marked by proteinuria microscopic hematuria and varying degrees of renal insufficiency B cells play a central role in the pathogenesis of SLE and LN with autoantibodies developing as an early finding and local tissue resident B cells producing pathogenic autoantibodies and driving inflammation and tissue damage over time 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 refractory lupus nephritis
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KYV101-003 | OTHER | None | None |