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A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

NCT07115745 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria \- 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. Exclusion Criteria \- 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.
Study design
Enrollment target: 125 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-04
Estimated completion: 2030-08-16
Last updated: 2026-03-04
Interventions
Genetic: BMS-986515Drug: FludarabineDrug: CyclophosphamideDrug: Tocilizumab
Primary outcomes
  • Number of participants with treatment-emergent adverse events (TEAEs) (Up to 24 months post BMS-986515 infusion)
  • Number of participants with serious AEs (SAEs) (Up to 24 months post BMS-986515 infusion)
  • Number of participants with AEs of special interest (AESIs) (Up to 24 months post BMS-986515 infusion)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (28)
Local Institution - 0041Not Yet Recruiting
Boston, Massachusetts, United States
Local Institution - 0037Not Yet Recruiting
Durham, North Carolina, United States
Local Institution - 0007Not Yet Recruiting
Camperdown, New South Wales, Australia
Local Institution - 0008Not Yet Recruiting
Brisbane, Queensland, Australia
Local Institution - 0013Not Yet Recruiting
Clayton, Victoria, Australia
Local Institution - 0040Not Yet Recruiting
Salvador, Estado de Bahia, Brazil
Local Institution - 0039Not Yet Recruiting
Porto Alegre, Brazil
Local Institution - 0038Not Yet Recruiting
São Paulo, Brazil
Local Institution - 0004Not Yet Recruiting
Prague, Praha 5, Czechia
Revmatologicky ustavRecruiting
Prague, Czechia
CHU Strasbourg-HautepierreRecruiting
Strasbourg, Alsace, France
Hopital Claude Huriez - CHU de LilleRecruiting
Lille, Nord, France
Local Institution - 0023Not Yet Recruiting
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Schleswig-Holstein Campus KielRecruiting
Kiel, Schleswig-Holstein, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinRecruiting
Berlin, Germany
Universitätsklinikum Carl Gustav Carus an der TU DresdenRecruiting
Dresden, Germany
Local Institution - 0031Not Yet Recruiting
Hamburg, Germany
Sheba Medical CenterRecruiting
Ramat Gan, Central District, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Pomeranian Voivodeship, Poland
Szpital Specjalistyczny nr 1 w BytomiuRecruiting
Bytom, Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w GliwicachRecruiting
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0017Not Yet Recruiting
Lodz, Łódź Voivodeship, Poland
ARENSIA Exploratory MedicineRecruiting
Cluj-Napoca, Cluj, Romania
Fundeni Clinical InstituteRecruiting
Bucharest, Romania
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Madrid, Comunidad de, Spain
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases · TrialPath