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KYV-101

Standard lymphodepletion regimen

Anti-CD20 mAB

Kyverna Therapeutics, Inc.

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis

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.

A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis

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 (KYSA-7)

Confirmed disability Progression on the EDSS scale. The EDSS scale ranges from 0 to 10 in 0.5- unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

Incidence and severity of adverse events (AEs)

Incidence and severity of adverse events of special interests (AESIs)

Incidence and severity of serious adverse events (SAEs)

Composite Confirmed Disability Progression (CCPD)

Levels of Chimeric antigen receptor positive (CAR-positive) T cell counts

Serum cytokines will be measured by multiplexed mesoscale discovery (MSD) assay and will include cytokines historically associated with potential CAR T toxicity (CRS and ICANS) such as gamma interferon (IFNg) and interleukin 6 (IL-6).

Percentage of participants who develop anti-KYV-101 antibodies by immunoassays)

Kyverna Therapeutics

Recurrence

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment.

Participants receive placebo given orally twice daily.

Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Masitinib

Placebo

Patrick Vermersch, MD, PhD

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes. The objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after 3 months of treatment versus matched placebo, in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1 design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96 weeks of treatment in the overall study population with subgroup analysis performed in stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).

Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

Multiple Sclerosis Quality of Life 54 items (MSQOL-54)

Multiple Sclerosis Functional Composite (MSFC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis	NCT06384976	Multiple Sclero... Multiple Sclero... Multiple Sclero...	KYV-101 Standard lympho... Anti-CD20 mAB	18 Years - 60 Years	Kyverna Therapeutics
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis	NCT01433497	Multiple Sclero... Multiple Sclero... Multiple Sclero...	Masitinib Placebo	18 Years - 75 Years	AB Science

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