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

2 1 1 1

What is this study about?

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.

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 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 Additional medication

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medical University Of Vienna Vienna Austria
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Bytom Poland
Odense University Hospital Odense Denmark
Universitaetsklinikum Erlangen AöR Erlangen Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Hopital Beaujon Clichy France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Uniklinikum Salzburg Salzburg Austria
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Hprgyspq Uazauyerjkvji Dh Lm Pqyybwzg Madrid Spain
Uqpyfdqwnr Hgyvozmt Cyvwauq Cologne Germany
Hzghnpxt Uwjqosvrmoxwy Dhseyezu Donostia / San Sebastian Spain
Npheerco Istiykpe Ocyghqlco Iub Mtfdp Sxiofkrdlnajvqwslnmdgvxcmvvx Ivehxump Bphcejml Cracow Poland
Hvlyhqjw Vwpg dwbcoqka Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.08.2025
Belgium Belgium
Not yet recruiting
01.08.2025
Denmark Denmark
Not yet recruiting
01.08.2025
France France
Not yet recruiting
01.08.2025
Germany Germany
Not yet recruiting
01.08.2025
Italy Italy
Not yet recruiting
01.08.2025
Poland Poland
Not yet recruiting
01.08.2025
Portugal Portugal
Not yet recruiting
01.08.2025
Spain Spain
Not yet recruiting
01.08.2025

Trial locations

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.

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 ID:
2024-519278-37-00
Protocol code:
CA061-1011
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

    Recruiting

    3 1
    Investigated drugs:
    Bulgaria Czechia Denmark Finland France Germany +9
  • BI 3000202 in Patients with Moderate to Severe Systemic Lupus Erythematosus

    Recruiting

    2 1
    Bulgaria Croatia Germany Hungary Poland Romania +1