Tests donor-derived CD19 CAR T cells in people with severe autoimmune diseases
Tests donor-derived CAR T cells in adults with severe, hard-to-treat autoimmune diseases.
Plain-language title generated from the registry record
Registry title: A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
Key facts
- Where
- Jerusalem and Ramat Gan, IsraelSee the 2 sites
- Phase
- Phase 1
Where in Israel
- Hadassah medical CenterJerusalem, IsraelTaking people
- Sheba medical centerRamat Gan, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Trial code
- NCT07115745EU 2024-517681-41-00
- Record updated
- 14 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Systemic lupus erythematosus (SLE) population:; Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR); 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; Inadequate response or intolerance to steroids and immunosuppressive therapies; Participants must have active disease at screening; Inflammatory myopathy (IIM) population:; Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria; Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies; Evidence of active disease; Systemic sclerosis (SSc) population:; Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis; 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:; 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.
Exclusion: Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders; 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; SLE population:; Participants who have SLE because of drugs or have other autoimmune diseases along with SLE; Rapidly deteriorating SSc, or history of severe kidney disease; RA population:; People who have additional autoimmune diseases along with RA; All participants:; IIM population:; Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage; SSc population:; People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control; Other protocol-defined inclusion/exclusion criteria apply.