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Study Comparing Rituximab and KYV-101 for Patients with Active, ACPA-Positive, Treatment-Resistant Rheumatoid Arthritis

Verified siteRegistered 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 Rheumatoid Arthritis, a condition where the immune system mistakenly attacks the joints, causing pain and swelling. The study will compare two treatments: Rituximab, a medication that helps reduce inflammation by targeting specific cells in the immune system, and KYV-101, an experimental therapy known as anti-CD19 CAR T cell therapy. This therapy involves modifying a patient's own immune cells to better target and destroy the cells causing the disease.

The purpose of the study is to assess the safety of these treatments in patients with active and treatment-resistant Rheumatoid Arthritis. Participants will receive either Rituximab or KYV-101 and will be monitored over time to see how their condition responds to the treatment. The study will also look at changes in specific antibodies in the blood, which are proteins that the immune system uses to fight off perceived threats.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on how these treatments can help manage Rheumatoid Arthritis and improve the quality of life for those affected by this condition. Participants will be observed for any side effects and changes in their symptoms to ensure the treatments are safe and effective.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A blood test is performed to check for ACPA positivity, which is a marker for rheumatoid arthritis. A score above 20 mU/ml is required.

    A DAS28-ESR score is calculated to assess disease activity. A score greater than 3.2 is necessary for participation.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of two treatment groups: rituximab or anti-CD19 CAR T cell therapy.

    Rituximab is administered as a 500 mg solution for infusion, given intravenously.

    Anti-CD19 CAR T cell therapy involves the infusion of modified T cells designed to target specific cells in the immune system.

  3. Step 3

    Treatment administration

    For those receiving rituximab, the infusion is administered according to the study schedule, with monitoring for any immediate reactions.

    Participants receiving CAR T cell therapy undergo a process where their T cells are collected, modified, and then reintroduced into the body.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for adverse events and serious adverse events throughout the study.

    Regular follow-up visits are scheduled to assess the safety and effectiveness of the treatment.

    Blood tests and other assessments are conducted to evaluate changes in disease markers and overall health.

  5. Step 5

    Evaluation of outcomes

    The primary focus is on the safety of the treatments, with specific attention to any side effects such as Cytokine Release Syndrome and Immune Cell Associated Neurotoxicity Syndrome.

    The effectiveness of the treatments is measured by the percentage of participants achieving ACPA seroconversion, indicating a reduction in disease activity.

    Additional assessments include changes in disease activity scores and quality of life measures over time.

  6. Step 6

    Study completion

    The study is expected to conclude by March 2027.

    Final evaluations are conducted to summarize the findings and determine the long-term effects of the treatments.

Who can join the trial?

12 criteria

  • Understand and voluntarily sign an informed consent form.
  • Men, unless they have had surgery to prevent having children, must agree to use two methods of birth control, like a condom and spermicide, during the trial and for 12 months after receiving the study treatment.
  • Women who can have children must have a negative pregnancy test at the start and agree to use a very effective birth control method for 12 months after receiving the study treatment.
  • Have an updated vaccination record according to recommendations for patients with weakened immune systems.
  • Be between 18 and 80 years old at the time of giving consent.
  • Be able to attend study visits and follow the study rules.
  • Meet the 2010 criteria for classifying **Rheumatoid Arthritis** (RA) by the American College of Rheumatology and the European League Against Rheumatism.
  • Have a positive test for **ACPA** (anti-citrullinated protein antibodies) with a level above 20 mU/ml at the start.
  • Have a **Disease Activity Score** (DAS28-ESR) greater than 3.2 at the start. This score measures how active the RA is.
  • Have not responded well to at least one traditional **DMARD** (disease-modifying antirheumatic drug) and at least two targeted or biological DMARDs after at least 3 months of treatment.
  • Have at least one swollen joint with certain activity levels seen on an ultrasound at the start.
  • Be willing to have a procedure to take a small sample from the joint lining, called a synovial puncture and biopsy.

Who cannot join the trial?

15 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other experimental treatment within the last 30 days.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a history of severe allergic reactions.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have a history of liver disease.
  • Patients who have a history of kidney disease.
  • Patients who have a history of lung disease.
  • Patients who have a history of blood disorders.
  • Patients who have a history of neurological disorders, such as seizures.
  • Patients who have a history of psychiatric disorders, such as depression or anxiety.
  • Patients who have a history of substance abuse.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

  • Rituximab

    is a medication used in this trial to help manage rheumatoid arthritis. It works by targeting and depleting B-cells, which are a type of white blood cell involved in the immune response. By reducing the number of these cells, rituximab can help decrease inflammation and slow down the progression of rheumatoid arthritis.

  • Anti-CD19 CAR T Cell Therapy

    is an advanced treatment being tested in this trial for rheumatoid arthritis. This therapy involves modifying a patient's own T-cells to better recognize and attack B-cells that contribute to the disease. The goal is to reduce the activity of the immune system that is causing joint inflammation and damage in rheumatoid arthritis.

What is already known about the treatment

  • Rituximab

    Rituximab is administered through an intravenous infusion, typically in a clinical setting. It is currently approved and widely used in medical practice for treating rheumatoid arthritis, among other conditions. The main therapeutic indication for rituximab in this context is rheumatoid arthritis, particularly in patients who have not responded to other treatments. Rituximab works by targeting and depleting B-cells, a type of white blood cell involved in the immune response, which helps reduce inflammation and slow disease progression. It is classified as a monoclonal antibody.

  • Anti-CD19 CAR T Cell Therapy

    This therapy involves the administration of genetically modified T cells, which are infused into the patient intravenously. It is currently being investigated in clinical trials for its safety and effectiveness in treating rheumatoid arthritis. The main therapeutic indication is for patients with treatment-resistant rheumatoid arthritis. The mechanism of action involves engineering T cells to target and destroy B-cells expressing the CD19 protein, thereby reducing inflammation and disease activity. This therapy falls under the category of cell-based immunotherapy.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation in the joint lining. Over time, this inflammation can cause joint damage, pain, swelling, and stiffness. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the wrists, knees, and ankles. As the condition advances, it may lead to joint deformity and loss of function. Rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514955-13-00Protocol codeCCM-RNT-202401Estimated enrolment16 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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