2025-524337-11-00招募中3 期
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 22
- 主要终点
- How much the amount of air a person can blow out of their lungs (called Forced Vital Capacity, or FVC) changes. This is measured in milliliters (mL).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NINTEDANIB, NINTEDANIB
Comparator
干预措施: NINTEDANIB (Drug)
CYCLOPHOSPHAMIDE
Auxiliary
干预措施: CYCLOPHOSPHAMIDE (Drug)
RITUXIMAB
Comparator
干预措施: RITUXIMAB (Drug)
FLUDARABINE PHOSPHATE
Auxiliary
干预措施: FLUDARABINE PHOSPHATE (Drug)
CD19-Targeted NEX-T CAR T
Test
干预措施: CD19-Targeted NEX-T CAR T (Drug)
TOCILIZUMAB
Comparator
干预措施: TOCILIZUMAB (Drug)
结局指标
主要结局
How much the amount of air a person can blow out of their lungs (called Forced Vital Capacity, or FVC) changes. This is measured in milliliters (mL).
How much the amount of air a person can blow out of their lungs (called Forced Vital Capacity, or FVC) changes. This is measured in milliliters (mL).
次要结局
- How much the skin thickness (measured by the Modified Rodnan Skin Score, or mRSS) changes.
- Changes in lung function (FVC in mL) or in skin thickness (mRSS).
- Changes in the percentage of predicted FVC (ppFVC), which compares a person’s lung function to what is expected for someone their age and size.
- Changes in how well the lungs transfer oxygen (called DLCO).
- How long it takes for the disease to get worse, starting from when a person joins the study.
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (22)
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