Study on the Safety and Effects of Rapcabtagene Autoleucel, Tocilizumab, Fludarabine Phosphate, and Cyclophosphamide for Patients with Rheumatoid Arthritis and Sjogren’s Disease

1 1 1 1

What is this study about?

This clinical trial is focused on studying two challenging diseases: rheumatoid arthritis and Sjögren’s disease. Rheumatoid arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. Sjögren’s disease is another immune system disorder that primarily affects the glands that produce tears and saliva, but in severe cases, it can involve other organs. The study will explore the effects of a new treatment called rapcabtagene autoleucel, also known by its code name YTB323. This treatment is a type of cell therapy, which involves using specially modified cells to target and treat the disease.

The purpose of the study is to assess the safety of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis and severe, refractory Sjögren’s disease with organ involvement. Participants will receive the treatment through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will also involve monitoring the behavior of the treatment in the body, known as cellular kinetics, to understand how it moves and changes over time.

In addition to rapcabtagene autoleucel, the study will also involve the use of other medications, including tocilizumab, fludarabine phosphate, and cyclophosphamide. These medications are commonly used in treating autoimmune diseases and will be administered as part of the study protocol. Some participants may receive a placebo instead of the active treatment. The study aims to gather information over a period of time to evaluate the treatment’s safety and its potential effectiveness in managing these complex diseases.

1 initial visit

Upon joining the study, you will have an initial visit. During this visit, your medical history will be reviewed, and a physical examination will be conducted. This is to ensure that you meet the study’s criteria.

You will be informed about the study procedures, and any questions you have will be answered. You will also be asked to sign a consent form to confirm your participation.

2 pre-treatment assessment

Before starting the treatment, several assessments will be conducted. These include blood tests, vital signs measurement, and an electrocardiogram (ECG) to check your heart’s activity.

These assessments help in establishing a baseline for your health status before the treatment begins.

3 treatment phase

The treatment involves receiving medications through an intravenous (IV) infusion. The medications include tocilizumab, fludarabine phosphate, cyclophosphamide, and rapcabtagene autoleucel.

The exact dosage, frequency, and duration of each medication will be explained to you by the study team. The treatment aims to assess the safety and effects of these medications on your condition.

4 monitoring and follow-up

Throughout the study, regular monitoring will be conducted to assess your health and the effects of the treatment. This includes repeated blood tests, vital signs checks, and ECGs.

You will be asked to report any side effects or changes in your health. This information is crucial for evaluating the safety of the treatment.

5 end of study visit

At the end of the study, a final visit will be scheduled. During this visit, a comprehensive assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

You will have the opportunity to discuss your experience and any concerns with the study team.

Who Can Join the Study?

  • Must provide a signed informed consent before joining the study.
  • Must be a man or woman aged between 18 and 65 years at the time of screening.
  • For those with Difficult to treat rheumatoid arthritis (D2T RA):
    • Must have a diagnosis of rheumatoid arthritis.
    • Must have experienced treatment failure with standard therapies.
    • Must show signs of active and progressive disease.
  • For those with Severe, refractory Sjogren’s disease (srSjD):
    • Must have a diagnosis of Sjogren’s disease.
    • Must have severe systemic disease that is difficult to treat, with moderate to high disease activity.

Who Cannot Join the Study?

  • Patients with severe, refractory Sjogren’s disease that affects organs cannot participate. This means the disease is very serious and does not respond to treatment.
  • Patients with difficult to treat rheumatoid arthritis are excluded. This refers to a type of arthritis that is hard to manage with standard treatments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Ubcbfnkyvh Hlxvwfdg Cbesjpc Cologne Germany
Hevbfblf Vhkl drfphcof Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
23.05.2025
Germany Germany
Recruiting
23.05.2025
Hungary Hungary
Not yet recruiting
23.05.2025
Italy Italy
Not yet recruiting
23.05.2025
Spain Spain
Recruiting
23.05.2025

Trial locations

Rapcabtagene autoleucel is a type of therapy that uses your own immune cells to help fight diseases like rheumatoid arthritis and Sjogren’s disease. In this treatment, some of your immune cells are taken from your body and modified in a lab to better recognize and attack the cells causing your disease. After this modification, the cells are put back into your body to help reduce symptoms and improve your condition. This therapy is being studied to see how safe it is and how well it works for people with difficult-to-treat rheumatoid arthritis and severe Sjogren’s disease that affects organs.

Sjogren’s Syndrome – Sjogren’s Syndrome is an autoimmune disorder characterized by the body’s immune system attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes. In severe cases, the disease can involve other organs, including the kidneys, liver, and lungs. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more severe organ involvement. Over time, the persistent dryness can lead to complications such as dental decay, oral infections, and vision problems. The disease can also cause fatigue and joint pain.

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. This inflammation can cause joint pain, swelling, and stiffness, often affecting the hands and feet. As the disease progresses, it can lead to joint damage and deformities. The inflammation can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The severity and progression of symptoms can vary widely among individuals.

Trial ID:
2024-514596-18-00
Protocol code:
CYTB323M12101B
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A Study of Cizutamig for Patients with Severe Autoimmune Inflammatory Diseases That Did Not Respond to Previous Treatments

    Recruiting

    1 1 1
    Germany
  • A Study of Idecabtagene Vicleucel CAR-T Cell Therapy for Patients with Autoimmune Diseases That Did Not Respond to B Cell Removal Treatment

    Recruiting

    1 1 1 1
    Investigated drugs:
    Germany