2023-510380-34-00招募中2 期
A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 58
- 主要终点
- Achievement of a treatment response as per the rCRISS50 definition at Week 52
研究概览
简要总结
To demonstrate the superiority of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion compared to rituximab, with respect to the proportion of participants achieving a Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) response at Week 52
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis (van den Hoogen et al 2013) and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy (LeRoy et al 1988)
- •Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit
- •Severe, progressive systemic sclerosis disease defined by at least one of the following: • Progressive systemic sclerosis-associated interstitial lung disease • Severe, progressive systemic sclerosis skin disease • Clinically significant systemic sclerosis-associated cardiac involvement at Screening
排除标准
- •Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator
- •Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab
- •Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator
- •Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy
- •Rheumatic disease other than dcSSc, (except secondary Sjogren’s syndrome or scleroderma myopathy), including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening
- •Participants with pre-existing pulmonary hypertension.
- •Significant renal pathology at Screening, including: • Scleroderma renal crisis • Confirmed diagnosis of glomerulonephritis
- •Participants with uncontrolled stage II hypertension at Screening.
结局指标
主要结局
Achievement of a treatment response as per the rCRISS50 definition at Week 52
Achievement of a treatment response as per the rCRISS50 definition at Week 52
次要结局
- Change from baseline in FVC% predicted at Week 52
- Change from baseline in mRSS at Week 52
- Change from baseline in HAQ-DI at Week 52
- Safety evaluation includes adverse events, laboratory parameters, vital signs, ECGs, and mortality
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (58)
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