Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384976
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-11-21
Brief Title:
KYSA-7 A Study of Anti-CD19 CAR T-Cell Therapy in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis
Sponsor:
Kyverna Therapeutics
Organization:
Kyverna Therapeutics
Study Overview
Official Title:
KYSA-7 A Phase 2 Open-Label Randomized Multicenter Study of KYV-101 an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell CD19 CAR T Therapy in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis
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 CD19 CAR T Therapy in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis
Detailed Description:
Multiple sclerosis MS is an autoimmune and neurodegenerative disease in which lymphocytes at first attack the myelin sheaths within the central nervous system CNS accompanied or later followed by axonal damage B cells play a central and multifunctional role in the immunopathogenesis of MS B cells present antigen to T cells in stimulating a pro-inflammatory immune cascade secrete pathogenic cytokines moderate T cell and myeloid cell functions form structural B cell meningeal follicles within the human central nervous system and produce pathogenic antibodies upon evolution to plasma cells
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 primary and secondary progressive multiple sclerosis
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 primary and secondary progressive multiple 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