NCT06138132

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis

A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis

Detailed description

Multiple Sclerosis (MS) is an immune-mediated neurodegenerative central nervous system disease that can lead to loss of vital neurologic function. The clinical course of MS from person to person is variable. Progressive Multiple Sclerosis (pMS) is marked by a history of neurologic worsening over time; and can occur following a prior history of defined relapses that has evolved to a non-relapsing state (previously termed "secondary progressive MS" (SPMS)) or from disease onset (termed "primary progressive MS" (PPMS)). There are now more than twenty FDA approved disease modifying therapies (DMTs) for MS in the United States. Most of these treatments have an approved FDA indication for relapsing disease. Several have a labeled indication for active secondary progressive MS, and only one has been FDA approved for primary progressive MS. There are no formally approved treatments for patients with non-relapsing progressive Multiple Sclerosis that is worsening, treatment refractory, and non-active as defined operationally by absence of relapse of magnetic resonance imaging evidence of inflammatory disease within the preceding two years. B cells play a central and multi-functional 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, act as reservoirs for Epstein-Barr virus (EBV) infection, 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 non-relapsing and progressive forms of MS.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
BIOLOGICAL	KYV-101 anti-CD19 CAR-T cell therapy	KYV-101 anti-CD19 CAR-T cell therapy
DRUG	Standard lymphodepletion regimen	Standard lymphodepletion regimen

Timeline

• Start date: 2024-04-10
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-11-18
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study