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Study of CC-97540 CD19-targeted CAR T cells in patients with systemic lupus erythematosus who did not respond to previous immunosuppressive treatment

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 focuses on evaluating a treatment for patients with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis, which are autoimmune conditions where the body's immune system attacks its own tissues. The main treatment being studied is called CD19-Targeted NEX-T CAR T (also known as CC-97540 or BMS-986353), which consists of specially modified immune cells designed to target specific cells in the body.

Before receiving the main treatment, patients will undergo preparation with three medications: cyclophosphamide, fludarabine, and tocilizumab. These medications are given through intravenous infusion to prepare the body for the CAR T cell treatment. The purpose of this study is to evaluate how effective CC-97540 is in treating patients with SLE who haven't responded well enough to previous treatments with steroids and other immune-suppressing medications.

The treatment process involves collecting the patient's own immune cells, modifying them in a laboratory to target specific disease-causing cells, and then returning them to the patient through an intravenous infusion. After the treatment, patients will be monitored to see if their disease symptoms improve and if they can achieve remission without needing other medications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial preparation

    Your treatment will begin with a preparation phase using three medications given through an intravenous (IV) line (directly into your vein):

    - Cyclophosphamide

    - Fludarabine

    - Fludarabine phosphate

  2. Step 2

    Main treatment administration

    You will receive CD19-Targeted NEX-T CAR T cells (CC-97540) through an IV line

    This is a special type of cell therapy where your own modified immune cells are used to treat lupus

    The treatment is given as a cell suspension for injection

  3. Step 3

    Additional medication

    Tocilizumab will be administered through an IV line as a supporting medication

  4. Step 4

    Monitoring period

    Your condition will be regularly monitored through various tests including:

    - Checking protein levels in your blood

    - Monitoring kidney function

    - Evaluating fatigue levels

    - Assessing pain levels

    The study will continue until June 2032

Who can join the trial?

6 criteria

  • Must be at least 16 years old and weigh at least 40 kilograms (88 pounds)
  • Must have been diagnosed with Systemic Lupus Erythematosus (SLE) according to specific medical criteria (EULAR/ACR 2019)
  • Must have previously tried treatment with glucocorticoids (steroid medications) and at least two different immune-suppressing medications for at least 3 months each, without adequate improvement
  • Must have active lupus disease as measured by:
    • A special assessment tool called BILAG (which measures how active the lupus is in different parts of the body)
    • Blood tests that show specific proteins related to lupus activity
    • For patients with kidney involvement (lupus nephritis), must have had a kidney biopsy (a small sample of kidney tissue examined under microscope) within the past 6 months

Who cannot join the trial?

14 criteria

  • Active severe lupus nephritis (inflammation of the kidneys caused by lupus) requiring high doses of steroids or other strong medications
  • History of severe allergic reactions to similar medications
  • Current or recent serious infections, including but not limited to:
    • Active tuberculosis (TB)
    • Hepatitis B or C
    • HIV infection
    • Significant heart, liver, or lung conditions that are not well controlled
    • Cancer diagnosis or treatment within the past 5 years (except for successfully treated skin cancer)
    • Pregnancy, breastfeeding, or planning to become pregnant
    • Recent vaccination with live vaccines (within 30 days before study start)
    • Participation in other clinical trials within the past 30 days
    • Use of prohibited medications that could interfere with the study drug
    • Mental health conditions that could affect ability to participate safely
    • Drug or alcohol abuse within the past year
    • Laboratory test results outside of acceptable ranges for the study
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Investigated drugs

CC-97540 (also known as BMS-986353) is a type of CAR T-cell therapy, which is a form of immunotherapy where a patient's own T cells (a type of immune cell) are modified in a laboratory to target and fight disease. In this case, the modified T cells are designed to target CD19, a protein found on certain immune cells. The therapy involves collecting the patient's T cells, genetically modifying them to recognize and attack cells expressing CD19, and then infusing them back into the patient. This treatment is being studied for patients with Systemic Lupus Erythematosus (SLE), including those with lupus nephritis who haven't responded well enough to steroid treatments and other immunosuppressive medications.

What is already known about the treatment

CC-97540 (BMS-986353) – A novel CD19-targeted CAR T-cell therapy administered through intravenous infusion, currently being investigated in Phase 2 clinical trials for treating Systemic Lupus Erythematosus (SLE) and Lupus Nephritis. This experimental treatment works by modifying the patient's own T-cells to target and eliminate B-cells expressing CD19, which play a key role in the autoimmune response associated with lupus. The therapy belongs to the class of cellular immunotherapies and represents a potential breakthrough for patients who haven't responded adequately to conventional treatments like glucocorticoids and immunosuppressants.

Investigated diseases

  • Systemic Lupus Erythematosus

    A chronic autoimmune disease where the body's immune system attacks its own tissues and organs. The condition can affect multiple body systems, including joints, skin, kidneys, blood cells, brain, heart, and lungs. People with lupus typically experience periods of symptoms (flares) followed by periods of remission. Common symptoms include fatigue, joint pain, skin rashes, and fever.

  • Lupus Nephritis

    A serious kidney complication that occurs when Systemic Lupus Erythematosus affects the kidneys. The condition causes inflammation in the small blood vessels and other tissues in the kidneys. Over time, this inflammation can impair the kidneys' ability to filter waste from the blood. Common signs include foamy urine, swelling in the legs, feet, or ankles, and high blood pressure.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519278-37-00Protocol codeCA061-1011Estimated enrolment89 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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