Phase 1 Study of KYV-101 Anti-CD19 CAR T-Cell Therapy for Adults With Non-relapsing and Progressive Multiple Sclerosis

What this Trial Is About

Researchers are investigating KYV-101, an anti-CD19 chimeric antigen receptor CAR T-cell therapy, in adults with non-relapsing and progressive forms of Multiple Sclerosis MS. MS is a neurodegenerative disease where the immune system attacks the nervous system, leading to worsening neurologic function over time. This study focuses on progressive MS patients whose disease is worsening but without recent inflammatory activity or relapses and who have not responded to existing treatments. The study involves administering KYV-101 CAR T cells following a standard lymphodepletion regimen to reduce certain immune cells before the treatment. This therapy aims to target and reduce B cells involved in MS progression. The trial is open-label and conducted at a single center, with participants receiving the investigational therapy and being closely monitored during the treatment and follow-up periods. Participants will undergo evaluations including safety assessments, laboratory tests, and clinical response measurements up to 12 months after treatment. Researchers will monitor dose-limiting toxicities, adverse events, pharmacokinetics, and pharmacodynamics of KYV-101. The study includes ongoing safety follow-up and detailed monitoring to understand the effects and response to the therapy over time.

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