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Study on the Safety and Effects of YTB323, Fludarabine Phosphate, and Tocilizumab in Patients with Severe, Refractory 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 a condition called Systemic Lupus Erythematosus (SLE), which is a disease where the immune system mistakenly attacks healthy tissues in the body. The study specifically looks at a severe form of this disease, known as severe, refractory Systemic Lupus Erythematosus (srSLE), which does not respond well to standard treatments. The main treatment being tested in this study is called YTB323, which is a type of cell therapy. This treatment involves using a patient's own immune cells, which are modified to better target and fight the disease. The study also involves other medications, including Fludarabine Phosphate, Cyclophosphamide, and Tocilizumab, which are used to prepare the body for the main treatment or manage side effects.

The purpose of the study is to assess the safety of YTB323 in patients with srSLE. Participants will receive the treatment through an infusion, which means it is delivered directly into the bloodstream. The study will monitor how the treatment affects the body over time, including any side effects and how the immune cells behave after being modified. The study will also look at how well the treatment works in reducing the symptoms of srSLE.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes checking vital signs, conducting blood tests, and evaluating any changes in the disease. The study aims to provide valuable information on the potential benefits and risks of using YTB323 for treating severe cases of SLE that have not responded to other treatments.

The research process

The trial runs in 7 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 checking renal, hepatic, cardiac, hematological, and pulmonary functions.
Eligibility is based on specific criteria, such as age between 18 and 65 years, and the presence of certain autoantibodies.
Step 2
Pre-treatment phase
Before starting the treatment, a detailed medical history is reviewed, and baseline measurements are taken.
This phase ensures that all necessary health parameters are recorded for comparison during and after the treatment.
Step 3
Treatment with cyclophosphamide and fludarabine
Cyclophosphamide and fludarabine are administered intravenously as part of the pre-conditioning regimen.
These medications help prepare the body for the main treatment by reducing immune activity.
Step 4
Administration of YTB323
YTB323, a dispersion for infusion, is administered intravenously.
This is the main treatment phase, where the medication is introduced to assess its safety and effectiveness.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to track vital signs, laboratory parameters, and any adverse events.
Follow-up visits are scheduled to assess the treatment's impact on the condition and to ensure safety.
Step 6
Use of tocilizumab if needed
Tocilizumab may be administered intravenously if certain side effects occur.
This medication helps manage specific immune responses that might arise during the treatment.
Step 7
End of study evaluation
At the end of the study, a comprehensive evaluation is conducted to assess the overall safety and effectiveness of the treatment.
This includes reviewing all collected data and comparing it to the initial baseline measurements.

Who can join the trial?

6 criteria

Must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.
Must have proper functioning of the kidneys, liver, heart, blood, and lungs.
Men and women with **Systemic Lupus Erythematosus (SLE)**, aged between 18 and 65 years, who meet specific classification criteria for SLE.
Must test positive for at least one of the following **autoantibodies** (proteins made by the immune system that mistakenly target the body's own tissues) at screening: **antinuclear antibodies (ANA)** at a certain level, or **anti-dsDNA** or **anti-Sm** above the normal limit.
Must have active and severe disease as defined by a specific score (SLEDAI-2K ≥8), excluding certain conditions like lupus headache, stroke, or brain disorders. Additionally, must have significant organ involvement related to SLE, such as kidney issues, moderate to severe heart inflammation, lung involvement, or blood vessel inflammation.
Must have not responded to at least two standard treatments for SLE, including specific drugs like mycophenolate or cyclophosphamide, unless these drugs caused side effects or are not suitable for you. Also, must not have responded to at least one biological treatment, unless it is not available or suitable for you.

Who cannot join the trial?

8 criteria

Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar treatments are excluded.
Patients with active infections that require treatment are not eligible.
Patients with other serious health conditions that could interfere with the study are excluded.
Patients who have received certain medications or treatments recently may not be eligible.
Patients who are unable to follow the study procedures or attend study visits are excluded.
Patients with a history of drug or alcohol abuse may not participate.
Patients who have participated in another clinical trial recently are not eligible.

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Verified sites

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

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Verified
Centre Hospitalier Universitaire De Lille
Lille, France

Trial locations

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Investigated drugs

YTB323 is an investigational therapy being studied for its safety and effectiveness in treating participants with severe, refractory systemic lupus erythematosus (srSLE). This therapy is designed to help manage the symptoms of srSLE, a condition where the immune system attacks the body's own tissues, causing inflammation and damage. The study aims to understand how well YTB323 works in controlling the disease and its potential side effects.

What is already known about the treatment

YTB323 – This medication is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. Currently, YTB323 is being studied in clinical trials, specifically in a phase 1/2 study, to evaluate its safety and effectiveness in treating severe, refractory systemic lupus erythematosus (srSLE). The main therapeutic indications for YTB323 include lupus nephritis and systemic lupus erythematosus. At the molecular level, YTB323 works by modifying the immune system to reduce inflammation and autoimmunity, although the exact mechanism is still under investigation. It is classified pharmacologically as an immunotherapy agent.

Investigated diseases

Lupus Nephritis
This is a kidney disorder that occurs as a complication of systemic lupus erythematosus (SLE), an autoimmune disease. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and potential damage. This condition can cause the kidneys to become less effective at filtering waste from the blood. Symptoms may include swelling in the legs, feet, or around the eyes, and high blood pressure. Over time, it can lead to changes in kidney function, which may be detected through laboratory tests. The progression of lupus nephritis can vary, with periods of flare-ups and remission.
Systemic Lupus Erythematosus
This is a chronic autoimmune disease where the immune system attacks healthy tissues throughout the body. It can affect various organs, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever, which can vary in severity and may come and go. The disease is characterized by periods of increased disease activity, known as flares, and periods of improvement or remission. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors. The progression of SLE is unpredictable, with symptoms and affected organs differing among individuals.