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Study on the Safety and Effectiveness of CABA-201, Fludarabine Phosphate, and Cyclophosphamide in Patients with Active Systemic Lupus Erythematosus

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 treatment of Systemic Lupus Erythematosus (SLE), a chronic autoimmune disorder. In SLE, the body's immune system mistakenly attacks its own tissues, leading to inflammation and damage in various organs. A severe form of this disease, known as lupus nephritis, affects the kidneys and can lead to significant health issues. The study will use a treatment called CABA-201, which involves a type of cell therapy using specially modified immune cells known as CD19-specific Chimeric Antigen Receptor T cells. These cells are designed to target and destroy specific immune cells that are involved in the disease process.

The purpose of the study is to evaluate the safety and tolerability of CABA-201 in individuals with active SLE over a period of 28 days. Participants will receive the treatment through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor participants for any side effects and changes in their condition during and after the treatment. This will help researchers understand how well the treatment works and how safe it is for patients with SLE.

Throughout the study, participants will undergo regular health checks, including physical examinations and laboratory tests, to assess their response to the treatment. The study aims to gather information on the effectiveness of CABA-201 in reducing the symptoms of SLE and improving the overall health of participants. This research could potentially lead to new treatment options for people living with this challenging autoimmune disorder.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
Blood tests and other diagnostic procedures may be performed to ensure adequate renal and hepatic function.
Step 2
Pre-infusion preparation
Before the infusion of the study medication, vaccinations must be up to date. Live vaccines should be administered at least 30 days prior, and non-live vaccines at least 2 weeks before the infusion.
Clinical stability is assessed through vital signs and other health indicators.
Step 3
Medication infusion
The study involves the administration of CABA-201, a type of treatment using modified cells, through an infusion.
Prior to receiving CABA-201, medications such as fludarabine phosphate and cyclophosphamide are administered via intravenous infusion to prepare the body. These medications help in conditioning the immune system.
Step 4
Monitoring period
After the infusion, a monitoring period of 28 days is required to evaluate safety and tolerability. This includes regular check-ups and assessments for any adverse effects.
Vital signs, physical examinations, and laboratory tests are conducted to ensure the patient's well-being.
Step 5
Long-term follow-up
The study includes a long-term follow-up period lasting up to 156 weeks. During this time, regular assessments are conducted to monitor health status and treatment effects.
Changes in specific health markers, such as white blood cell counts and antibody levels, are tracked over time.

Who can join the trial?

11 criteria

Able to provide informed consent, meaning you understand the study and agree to participate.
Diagnosed with active Systemic Lupus Erythematosus (SLE). This includes those with or without lupus nephritis (LN), a kidney-related condition. If you have LN, your urine protein-to-creatinine ratio should be 1 mg/mg or higher, even after treatment.
Have adequate kidney function.
Have adequate liver function.
Received all recommended vaccinations, including COVID-19 vaccines, according to health guidelines for people with weakened immune systems. Live vaccines should be given at least 30 days before the study starts, and non-live vaccines at least 2 weeks before.
Be clinically stable, meaning your vital signs like heart rate and blood pressure are normal at the time of screening.
If you are a woman who can have children and are sexually active, you must agree to use one highly effective method of birth control.
Be between 18 and 65 years old.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means you are fully active or have some symptoms but can carry out light work.
Have a clinical diagnosis of SLE based on specific criteria set by medical organizations.
Have a positive test for antinuclear antibodies (ANA) or anti-dsDNA antibodies at the time of screening. These are specific markers in the blood that help diagnose SLE.

Who cannot join the trial?

9 criteria

Having an active form of Systemic Lupus Erythematosus (SLE), which is a long-term condition where the immune system attacks the body's own tissues.
Being under the age of 18 or over the age of 65.
Being pregnant or breastfeeding.
Having a history of severe allergic reactions to medications.
Having any other serious health conditions that could interfere with the study.
Using certain medications that might affect the study results.
Having participated in another clinical trial recently.
Having a history of drug or alcohol abuse.
Being unable to follow the study procedures or attend study visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centre Hospitalier Universitaire De Poitiers
Poitiers, France
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Hopital Beaujon
Clichy, France

Trial locations

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Investigated drugs

CABA-201 is a type of therapy that uses the patient's own immune cells, called T cells, which are modified to better recognize and attack certain cells in the body. In this study, CABA-201 is being tested for its safety and effectiveness in treating people with active Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues. The goal is to see if this therapy can help manage the symptoms of SLE by targeting specific cells involved in the disease.

What is already known about the treatment

CABA-201 – This medication is administered as an infusion of autologous CD19-specific chimeric antigen receptor T cells, commonly known as CAR T cells. It is currently being studied in clinical trials for its safety and effectiveness in treating active systemic lupus erythematosus (SLE), a chronic autoimmune disorder. The main therapeutic indication is for patients with SLE, particularly those experiencing severe manifestations like lupus nephritis. At the molecular level, CABA-201 works by targeting and eliminating B cells that produce harmful antibodies, thereby reducing inflammation and tissue damage. It is classified under immunotherapy, specifically as a CAR T cell therapy.

Investigated diseases

Systemic Lupus Erythematosus (SLE) – Systemic lupus erythematosus is a chronic autoimmune disorder where the body's immune system mistakenly attacks its own tissues. This condition is characterized by the production of autoantibodies and abnormal B cell function. SLE can vary in severity and may cause damage to various organs over time. One of the severe manifestations of SLE is lupus nephritis, which affects the kidneys and can lead to significant health issues. The disease often presents with periods of flares and remissions, where symptoms can worsen or improve. Common symptoms include joint pain, skin rashes, and fatigue, but it can affect many parts of the body.