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Study of BMS-986353, CD19-CAR T Cells, versus SoC in Participants with Active SSc (Breakfree-SSc)
EU CTIS ID: 2025-524337-11-00
What this study is testing
The main goal of this study is to test how well BMS-986353 can help patients with active Systemic Sclerosis (SSc) and Interstitial Lung Disease (ILD) to improve the functioning of their lungs, compared to the standard treatments.
- Therapeutic confirmatory (Phase III)
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
- Have systemic sclerosis (SSc), as defined by the ACR / EULAR 2013 criteria
- Have positive auto-antibodies
- Have signs of activity in their lungs from SSc, seen on a scan called high-resolution computed tomography (HRCT)
- Have at least one of these manifestations caused by active SSc: Swollen or inflamed joints, Muscle inflammation, Heart inflammation, New or worse skin thickening, High levels of inflammation in the blood
- Have tried at least one SSc treatment for 6 months, which did not work well enough or caused side effects
You likely can't join if
- Need oxygen to breathe or have very poor lung function
- Moderate to severe high blood pressure in the lungs (pulmonary arterial hypertension) requiring two special treatments
- Serious lung problems, like chronic obstructive pulmonary disease (COPD) or asthma requiring daily steroid pills; smoking cigarettes or e-cigarettes in the last 3 months, or not willing to stop smoking during the study
- Serious stomach or gut problems requiring feeding through a vein (total parenteral nutrition)
- Gangrene (dead tissue) in a finger or toe
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Canada
- United States
- United Kingdom
- Switzerland
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Canada; United States; United Kingdom; Switzerland. 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.