NCT07335562尚未招募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)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company110 个研究点 分布在 10 个国家目标入组 92 人开始时间: 2026年8月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 110
- 主要终点
- The absolute change from baseline in Forced Vital Capacity (FVC) in mL
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
详细描述
Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:.
- •i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.
- •ii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:.
- •A. Arthritis.
- •B. Myositis.
- •C. Carditis.
- •D. Progressive skin disease.
- •E. Elevated inflammatory markers.
- •- Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation.
排除标准
- •Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening.
- •Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
- •Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening.
- •Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).
- •Participants must not have current gangrene of a digit
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A: BMS-986353
Experimental
干预措施: Cyclophosphamide (Drug)
Arm B: Standard of Care
Experimental
干预措施: Tocilizumab (Drug)
Arm A: BMS-986353
Experimental
干预措施: Fludarabine (Drug)
Arm B: Standard of Care
Experimental
干预措施: Nintedanib (Drug)
Arm A: BMS-986353
Experimental
干预措施: BMS-986353 (Drug)
Arm B: Standard of Care
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
The absolute change from baseline in Forced Vital Capacity (FVC) in mL
时间窗: At 12 months
次要结局
- The absolute change from baseline in Modified Rodnan Skin Score (mRSS)(At month 12)
- The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score(Up to month 36)
- Time to progression, defined as the time from randomization to progressive disease(Approximately 54 months)
- The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue(Up to month 36)
- The change from baseline in Scleroderma Clinical Index (ScleroID)(Up to month 36)
- The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI)(Up to month 36)
- The change from baseline in PROMIS-29(Up to month 36)
- The change from baseline in St. George's Respiratory Questionnaire (SGRQ)(Up to month 36)
- The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale(Up to month 36)
- The change from baseline in EQ-5D-5L Utility Index(Up to month 36)
- The absolute change from baseline in FVC in mL(Up to month 36)
- The absolute change from baseline in FVC in mL/year(Up to month 36)
- The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC)(Up to month 36)
- The relative change from baseline in ppFVC(Up to month 36)
- The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO)(Up to month 36)
研究者
研究点 (110)
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