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Study of CC-97540 (BMS-986353), CD19-CAR T Cells, in Participants with Active SLE Despite Immunosuppressants (Breakfree-SLE)
EU CTIS ID: 2024-519278-37-00
What this study is testing
To evaluate the efficacy of CC-97540 in participants with SLE
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Be at least 16 years old and must have a body weight of ≥ 40 kg
- Have Systemic Lupus Erythematosus (SLE), as defined by the EULAR/ACR 2019 criteria
- Have tried glucocorticoids and at least two different immune-suppressing drugs for SLE, for at least three months each, but these treatments didn't work well enough
- Have active SLE determined by a scoring system called BILAG (a tool to measure SLE disease activity), and by testing for certain proteins in the blood that are signs of SLE
- Have a specific type of kidney disease related to SLE (lupus nephritis [LN]), they must have had a kidney biopsy within the last six months.
You likely can't join if
- Other diseases or conditions, or be receiving treatments, that might make it hard to tell if the study drug, CC-97540, is working
- Uncontrolled infections
- Serious heart conditions
- Unresolved problems with their central nervous system
- Cancer or a disease where the body makes too many lymphocytes, unless they have been free of the disease for at least two years
- Women who are pregnant, nursing, or planning to become pregnant
See the full eligibility criteria
- Be at least 16 years old and must have a body weight of ≥ 40 kg
- Have Systemic Lupus Erythematosus (SLE), as defined by the EULAR/ACR 2019 criteria
- Have tried glucocorticoids and at least two different immune-suppressing drugs for SLE, for at least three months each, but these treatments didn't work well enough
- Have active SLE determined by a scoring system called BILAG (a tool to measure SLE disease activity), and by testing for certain proteins in the blood that are signs of SLE
- Have a specific type of kidney disease related to SLE (lupus nephritis [LN]), they must have had a kidney biopsy within the last six months.
- Other diseases or conditions, or be receiving treatments, that might make it hard to tell if the study drug, CC-97540, is working
- Uncontrolled infections
- Serious heart conditions
- Unresolved problems with their central nervous system
- Cancer or a disease where the body makes too many lymphocytes, unless they have been free of the disease for at least two years
- Women who are pregnant, nursing, or planning to become pregnant
- Having had certain types of cell therapies or a stem cell transplant
- Having received a live vaccine within six weeks before starting the study drug
- Poor organ function, as determined by lab tests at the study site
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- Japan
- Israel
- Argentina
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; Japan; Israel; Argentina; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.