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Study on the Effects of Rapcabtagene Autoleucel in Patients with Systemic Lupus Erythematosus and Active, Refractory Lupus Nephritis

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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 rapcabtagene autoleucel in people with a condition known as systemic lupus erythematosus (SLE), which is a disease where the immune system attacks the body's own tissues. Specifically, the study targets those with a severe form of SLE that affects the kidneys, called lupus nephritis. The purpose of the study is to compare the effectiveness and safety of rapcabtagene autoleucel against the standard treatments currently used for this condition.

Participants in the study will receive either rapcabtagene autoleucel or one of the standard treatments, which may include medications like cyclophosphamide, voclosporin, belimumab, rituximab, mycophenolate mofetil, tacrolimus, or fludarabine phosphate. Rapcabtagene autoleucel is a type of cell therapy that involves modifying a person's own immune cells to better fight the disease. The study will last for about a year, during which participants will be monitored to see how well the treatment works and to check for any side effects.

The study is designed to help researchers understand if rapcabtagene autoleucel can provide better outcomes for patients with lupus nephritis compared to the current standard treatments. Participants will be assessed for improvements in their condition and any changes in their health over the course of the study. This research aims to find more effective ways to manage and treat lupus nephritis, potentially offering new hope for those affected by this challenging condition.

The research process

The trial runs in 7 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 current health status.

    Blood tests and other diagnostic procedures may be performed to ensure the presence of systemic lupus erythematosus (SLE) with active lupus nephritis (LN).

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to receive either the investigational treatment, rapcabtagene autoleucel, or the standard of care (SOC).

    The investigational treatment involves a single infusion of CAR-positive viable T cells following a preparatory phase called lymphodepletion.

  3. Step 3

    Lymphodepletion

    Before receiving the investigational treatment, participants undergo lymphodepletion. This process involves the administration of medications to reduce the number of certain immune cells.

    Medications used may include cyclophosphamide and fludarabine phosphate, administered through intravenous infusion.

  4. Step 4

    Administration of rapcabtagene autoleucel

    Following lymphodepletion, participants receive a single infusion of rapcabtagene autoleucel.

    This infusion is administered intravenously and is designed to target and modify specific immune cells.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored regularly to assess the treatment's effects and any potential side effects.

    Regular check-ups include blood tests, urine tests, and other assessments to evaluate kidney function and overall health.

  6. Step 6

    Evaluation of clinical response

    The primary goal is to evaluate the clinical response at Week 52, focusing on remission and kidney function improvement.

    Secondary evaluations include fatigue levels, disease activity scores, and safety assessments.

  7. Step 7

    Completion of study

    The study concludes with a final assessment to determine the long-term effects of the treatment.

    Participants may be asked to continue follow-up visits to monitor their health beyond the study period.

Who can join the trial?

7 criteria

  • You must sign a form to show you agree to take part in the study.
  • You should be a man or woman with **systemic lupus erythematosus (SLE)**, which is a condition where the immune system attacks the body, and be between 18 and 65 years old.
  • You need to have certain antibodies in your blood. These are proteins that the immune system makes. The specific antibodies are called **antinuclear antibodies (ANA)**, **anti-dsDNA**, or **anti-Sm**.
  • You must have **active lupus nephritis**, which is a kidney problem caused by lupus, but it should not be a long-term issue. This needs to be confirmed by a kidney biopsy, which is a test where a small piece of kidney tissue is examined.
  • Your **urine protein creatinine ratio (UPCR)**, a test that measures protein in your urine, should be between 1.0 and less than 7.0 grams per gram in a 24-hour urine collection.
  • Your **SLEDAI-2K score**, which measures lupus activity, should be 6 points or more. This score does not include points for fever, lupus headache, hair loss, or brain issues.
  • You should have tried at least two different treatments for lupus nephritis, each for at least 3 months, but they did not work well enough. These treatments include certain medications like **cyclophosphamide**, **mycophenolic acid**, **belimumab**, **azathioprine**, **rituximab**, **cyclosporin**, **tacrolimus**, or **voclosporin**.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than systemic lupus erythematosus (SLE) with active, difficult-to-treat lupus nephritis (LN) cannot participate. Systemic lupus erythematosus (SLE) is a disease where the immune system attacks the body, and lupus nephritis (LN) is when this disease affects the kidneys.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not meet the gender requirements for the study cannot participate.
  • Patients who are considered part of a vulnerable population, meaning they might need special protection or care, cannot participate.
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Investigated drugs

  • Rapcabtagene Autoleucel

    is a type of gene therapy used in this clinical trial. It involves modifying a patient's own T cells to help them better recognize and attack certain cells in the body. This therapy is being tested to see if it can improve the condition of patients with systemic lupus erythematosus (SLE) who have active, difficult-to-treat lupus nephritis (LN).

  • Standard of Care (SOC)

    refers to the usual treatment given to patients with systemic lupus erythematosus and lupus nephritis. This can include a variety of medications and therapies that are commonly used to manage symptoms and control the disease. The trial compares the new therapy, rapcabtagene autoleucel, to these standard treatments to see which is more effective.

What is already known about the treatment

Rapcabtagene autoleucel – This medication is administered as a single infusion of CAR-positive viable T cells following a process called lymphodepletion. It is currently being studied in clinical trials for its effectiveness and safety in treating systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). The main therapeutic indication is to improve clinical response in patients with this condition. At the molecular level, rapcabtagene autoleucel works by modifying the patient's own T cells to better target and attack specific cells involved in the disease process. It falls under the pharmacological classification of gene therapy and immunotherapy.

Investigated diseases

Systemic Lupus Erythematosus (SLE) – This is an autoimmune disease where the body's immune system mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms vary widely among individuals and can include fatigue, joint pain, rash, and fever. The disease often progresses with periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, SLE can lead to complications in various organs, particularly the kidneys, known as lupus nephritis. The severity and progression of the disease can differ greatly from person to person.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510150-17-00Protocol codeCYTB323J12201Estimated enrolment166 patientsSponsorNovartis Pharma AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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