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
- Bucharest and Cluj-Napoca, RomaniaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe autoimmune disease that did not respond to usual treatment: lupus, inflammatory myopathy, systemic sclerosis or rheumatoid arthritis.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Severe, refractory (hard to treat) disease that is active. Lupus, inflammatory myopathy, systemic sclerosis (skin and/or lung disease that is getting worse) or difficult to treat rheumatoid arthritis.
- Earlier treatment
- Poor response to, or could not tolerate, earlier treatments such as steroids and immunosuppressive therapies. Previous CAR-T cell therapy is not allowed.
- Biomarker or test result
- For lupus: positive for at least one of these antibodies at screening: anti-nuclear, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm.
Main reasons for not taking part
- Any other systemic autoimmune disease
- Pregnant or nursing women
- Active hepatitis B, hepatitis C or HIV
- Past cancer, or uncontrolled or active infection
- Previous CAR-T cell therapy
Read by machine on 9 November 2026.
Where in Romania
- Institutul Clinic FundeniBucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.