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Study on Anti-CD19 CAR T-Cell Therapy for Patients with Refractory Systemic Autoimmune Diseases Using Levetiracetam, Fludarabine, and a Drug Combination

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 the effects of a treatment called anti-CD19 CAR T-cell therapy in people with certain types of autoimmune diseases that are difficult to treat. These diseases include Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Dermatomyositis/Polymyositis (DM/PM), and Antineutrophil Cytoplasmic Antibody-Associated Vasculitis (AAV). The treatment involves using a patient's own immune cells, which are modified in a laboratory to better target and fight the disease.

The purpose of the study is to evaluate the safety and initial effectiveness of this therapy in patients with active forms of these diseases. Participants will receive the treatment through an intravenous infusion, which means it is delivered directly into the bloodstream. The study will monitor participants for any side effects and changes in their condition over a period of time. Some participants may receive a placebo, which is a substance with no active treatment, to compare the effects of the therapy.

Throughout the study, researchers will keep track of how the treatment affects the immune system and the levels of certain antibodies in the blood. The study aims to provide valuable information on whether this therapy can be a safe and effective option for people with these challenging autoimmune diseases. The trial is expected to continue until early 2026, with recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of levetiracetam through an intravenous infusion. This medication is given to manage symptoms and prepare the body for further treatment.

    Following levetiracetam, fludarabine is administered intravenously. This medication helps to suppress the immune system, making the body more receptive to the upcoming therapy.

  2. Step 2

    Preparation for cell therapy

    The next step involves the administration of cyclophosphamide through an intravenous infusion. This medication further prepares the immune system for the introduction of modified cells.

  3. Step 3

    Cell therapy administration

    The core of the treatment involves the infusion of autologous T-cells that have been modified with a lentiviral vector to express a chimeric antigen receptor targeting CD19. This is a specialized cell suspension for injection designed to target and modify specific immune cells.

  4. Step 4

    Supportive care

    To manage potential side effects, tocilizumab is administered intravenously. This medication helps to control inflammation and other immune responses that may occur after the cell therapy.

  5. Step 5

    Monitoring and follow-up

    After the administration of the cell therapy, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any signs of cytokine release syndrome or neurotoxicity, as well as monitoring the levels of B cells and CAR T cells in the blood.

    The follow-up period extends up to 24 weeks, with long-term monitoring to ensure the persistence of the treatment effects and to observe any changes in disease-associated antibodies.

Who can join the trial?

6 criteria

  • Participants must understand and voluntarily sign an informed consent form, which includes written consent for data protection.
  • Participants must be adults aged **18 years or older** and **younger than 65 years** at the time of consent.
  • Male participants, unless they have had surgery to become sterile, must agree to use two acceptable methods of contraception, such as spermicide and a condom, during the trial and avoid fathering a child from the time of signing the informed consent form until 12 months after receiving the investigational medicine.
  • Females who can have children must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method, with a very low chance of failure, starting from the time of signing the informed consent form and for 12 months after receiving the investigational medicine.
  • Participants must be able to follow the study visit schedule and meet other requirements of the study protocol.
  • Participants must have received two doses of a vaccine against **SARS-CoV-2** (the virus that causes COVID-19) within the last 6 months.

Who cannot join the trial?

8 criteria

  • Patients who have an active infection that is not well controlled.
  • Patients who have a history of severe allergic reactions to similar treatments.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of cancer within the last 5 years, except for certain skin cancers.
  • Patients who have a serious heart condition that is not stable.
  • Patients who have a history of drug or alcohol abuse within the last year.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Anti-CD19 CAR T-Cell Therapy is a treatment being studied for its safety and effectiveness in people with certain autoimmune diseases. This therapy involves using a patient's own immune cells, which are modified in a laboratory to better recognize and attack specific cells in the body that are causing the disease. The goal is to help manage conditions like systemic lupus erythematosus (SLE), systemic sclerosis (SSc), dermatomyositis/polymyositis (DM/PM), and antineutrophil cytoplasmic antibody-associated vasculitis (AAV).

What is already known about the treatment

Anti-CD19 CAR T-Cell Therapy – This medication is administered through an infusion, where modified T-cells are introduced into the patient's bloodstream. It is currently being studied in clinical trials for its potential use in treating refractory systemic autoimmune diseases, such as lupus and scleroderma. The therapy works by targeting and eliminating B-cells that express the CD19 protein, which are involved in the autoimmune response. It falls under the pharmacological classification of immunotherapy, specifically as a type of cell-based therapy.

Investigated diseases

  • Systemic Lupus Erythematosus (SLE)

    This is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, rash, and fever. The disease can vary greatly in severity and can have periods of flares and remissions. Over time, it may lead to damage in the affected organs.

  • Systemic Sclerosis (SSc)

    This is a chronic connective tissue disease characterized by changes in the skin, blood vessels, muscles, and internal organs. It involves the overproduction of collagen, leading to thickening and tightening of the skin. The disease can also affect internal organs, causing complications in the heart, lungs, and digestive system. Symptoms may include skin hardening, Raynaud's phenomenon, and joint pain. The progression and severity can vary widely among individuals.

  • Dermatomyositis (DM)

    This is an inflammatory disease marked by muscle weakness and a distinctive skin rash. It primarily affects the muscles and skin, leading to muscle inflammation and skin changes. Symptoms often include muscle weakness, skin rashes, and sometimes difficulty swallowing. The disease can progress slowly or rapidly, affecting the ability to perform daily activities. It may also involve other organs, such as the lungs and heart.

  • Polymyositis (PM)

    This is an inflammatory muscle disease that causes muscle weakness, primarily affecting the muscles closest to the trunk of the body. It involves inflammation and degeneration of muscle tissue, leading to muscle weakness and fatigue. Symptoms typically include difficulty climbing stairs, lifting objects, or reaching overhead. The disease can progress over weeks to months, affecting the ability to perform daily tasks. It may also be associated with other autoimmune conditions.

  • Antineutrophil Cytoplasmic Antibody-Associated Vasculitis (AAV)

    This is a group of diseases characterized by inflammation of blood vessels, which can restrict blood flow and damage vital organs and tissues. It primarily affects small to medium-sized blood vessels, leading to organ damage. Symptoms can vary widely but often include fatigue, fever, weight loss, and organ-specific symptoms. The disease can progress rapidly, causing significant damage if not managed. It often requires long-term monitoring and management.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511293-74-01Protocol codeRF-2021-12375251Estimated enrolment8 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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