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Study of KYV-101 Therapy for Patients with Refractory Primary and Secondary Progressive Multiple Sclerosis

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for Primary and Secondary Progressive Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, leading to worsening physical disability. The treatment being tested is called KYV-101, which is a type of therapy that uses the patient's own immune cells, specifically T-cells, that are modified to better target and fight the disease. This therapy is known as Anti-CD19 CAR T-cell Therapy, where CAR stands for Chimeric Antigen Receptor, a special receptor added to the T-cells to help them recognize and attack the disease more effectively.

The purpose of the study is to evaluate how effective KYV-101 is in treating this form of multiple sclerosis. Participants in the study will receive the treatment and be monitored over a period of time to see how their condition changes. The study will look at various aspects, such as changes in physical disability, the number of relapses, and any changes observed in brain scans using MRI (Magnetic Resonance Imaging). The study will also monitor the presence of specific cells and proteins in the body to understand how the treatment is working.

Throughout the study, participants will receive either the KYV-101 treatment or a placebo, and their progress will be tracked to assess the treatment's impact. The study aims to provide valuable information on whether this new therapy can help manage or slow down the progression of Primary and Secondary Progressive Multiple Sclerosis. The study is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age and medical history. The study focuses on individuals aged 18 to 60 with a diagnosis of primary or secondary progressive multiple sclerosis.

    Participants must have a history of treatment with anti-CD20 monoclonal antibodies and evidence of worsening physical disability over at least six months.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of KYV-101, an anti-CD19 CAR T-cell therapy. This is a specialized treatment using the participant's own cells, modified to target specific cells in the body.

    The treatment is administered intravenously, meaning it is delivered directly into the bloodstream through a vein.

  3. Step 3

    Monitoring and follow-up

    Participants are monitored for changes in disability progression, using a scale known as the Expanded Disability Status Scale (EDSS).

    Regular assessments include brain MRI scans to evaluate changes in brain volume and the presence of lesions.

    Blood tests are conducted to measure T-cell counts, B-cell counts, and the presence of any antibodies against the treatment.

  4. Step 4

    End of study evaluation

    The study concludes with a comprehensive evaluation of the participant's condition, comparing data from the start of the study to the end.

    The primary focus is on confirmed disability progression and any changes in clinical disability.

Who can join the trial?

4 criteria

  • The person must be between 18 and 60 years old.
  • The person must have been diagnosed with either Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
  • The person must have been treated with a type of medication called anti-CD20 monoclonal antibodies (mAb) and still show signs of worsening physical disability for at least 6 months. There should be proof of this worsening within the last 2 years.
  • If the person has active SPMS, they should have tried another treatment called disease-modifying therapy (DMT) and either not responded well to it or could not tolerate it. An example of such a treatment is a sphingosine-1-phosphate (S1P) receptor modulator, if available.

Who cannot join the trial?

4 criteria

  • Patients with **Primary or Secondary Progressive Multiple Sclerosis** cannot participate. This is a type of multiple sclerosis, which is a disease affecting the brain and spinal cord.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it means that only people of certain ages can join.
  • Patients who do not belong to the specified clinical trial group cannot participate. This means that only people with certain characteristics or conditions can join.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups of people who might need special protection or care.
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Investigated drugs

KYV101 is a type of therapy that uses your own immune cells to fight disease. In this trial, it is being tested for people with a form of multiple sclerosis that does not respond to other treatments. The therapy involves taking your immune cells, modifying them to better target the disease, and then putting them back into your body. This approach aims to help your immune system attack the cells that are causing the disease.

What is already known about the treatment

KYV101 – KYV101 is an investigational therapy administered as an infusion, specifically designed for individuals with refractory primary or secondary progressive multiple sclerosis. Currently, it is in the clinical trial phase, with ongoing studies to assess its effectiveness and safety. The main therapeutic indication for KYV101 is to treat progressive forms of multiple sclerosis that do not respond to standard treatments. At the molecular level, KYV101 works by using genetically modified T cells that target and destroy cells expressing the CD19 antigen, which is believed to play a role in the disease process. It is classified pharmacologically as a chimeric antigen receptor (CAR) T cell therapy.

Investigated diseases

  • Primary Progressive Multiple Sclerosis

    This is a form of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. It primarily affects the spinal cord and can lead to increasing disability over time. Patients may experience problems with walking, balance, and coordination, as well as muscle stiffness and weakness. The progression of symptoms can vary widely among individuals, with some experiencing a steady decline and others having periods of stability.

  • Secondary Progressive Multiple Sclerosis

    This form of multiple sclerosis initially begins as relapsing-remitting MS, where patients experience episodes of new or worsening symptoms followed by periods of recovery. Over time, the disease transitions into a phase where there is a steady progression of disability, with or without occasional relapses. Symptoms may include increased difficulty with mobility, fatigue, and cognitive changes. The rate of progression can differ among individuals, with some experiencing a gradual decline and others having more rapid changes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511168-10-00Protocol codeKYV101-007Estimated enrolment134 patientsSponsorKyverna Therapeutics Inc.

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