A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company55 个研究点分布在 10 个国家目标入组 125 人开始时间: 2025年9月4日最近更新: 2026年7月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 125
试验地点: 55
主要终点: Number of participants with AEs of special interest (AESIs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•- Systemic lupus erythematosus (SLE) population:.
•i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
•ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody.
•iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.
•iv) Participants must have active disease at screening.
•- Inflammatory myopathy (IIM) population:.
•i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
•ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.
•iv) Evidence of active disease.
•- Systemic sclerosis (SSc) population:.
•i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.
•ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease.
•- Rheumatoid arthritis (RA) population:.
•i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy.

排除标准

•- All participants:.
•i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening.
•vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.
•SLE population:.
•i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
•IIM population:.
•i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
•SSc population:.
•i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.
•ii) Rapidly deteriorating SSc, or history of severe kidney disease.
•RA population:.
•i) People who have additional autoimmune diseases along with RA.
•Other protocol-defined inclusion/exclusion criteria apply.

研究组 & 干预措施

BMS-986515 Administration

Experimental

干预措施: BMS-986515 (Genetic)

BMS-986515 Administration

Experimental

干预措施: Tocilizumab (Drug)

BMS-986515 Administration

Experimental

干预措施: Cyclophosphamide (Drug)

BMS-986515 Administration

Experimental

干预措施: Fludarabine (Drug)