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NCT07115745PHASE1Recruiting

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

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Start Date

9/4/2025

Completion Date

8/16/2030

Summary

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

Age Range: 18 years to No maximum

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.

Interventions

GENETIC

BMS-986515

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Tocilizumab

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Conditions

Refractory Autoimmune Diseases

Locations

Brigham And Womens Hospital

Boston, Massachusetts 02115

United States

Duke University

Durham, North Carolina 27705-2771

United States

Local Institution - 0007

Camperdown, New South Wales 2050

Australia

Local Institution - 0008

Brisbane, Queensland 4029

Australia

Local Institution - 0013

Clayton, Victoria 3168

Australia

Local Institution - 0040

Salvador, Estado de Bahia 41253-190

Brazil

Local Institution - 0039

Porto Alegre, 0

Brazil

Local Institution - 0038

São Paulo, 01508-010

Brazil

Local Institution - 0004

Prague, Praha 5 150 06

Czechia

Revmatologicky ustav

Prague, 12850

Czechia

CHU Strasbourg-Hautepierre

Strasbourg, Alsace 67098

France

Hopital Claude Huriez - CHU de Lille

Lille, Nord 59037

France

Universitaetsklinikum Duesseldorf

Düsseldorf, North Rhine-Westphalia 40225

Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein 24105

Germany

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117

Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307

Germany

Local Institution - 0031

Hamburg, 20246

Germany

Sheba Medical Center

Ramat Gan, Central District 5262100

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship 80-952

Poland

Szpital Specjalistyczny nr 1 w Bytomiu

Bytom, Silesian Voivodeship 41-902

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach

Gliwice, Silesian Voivodeship 44-100

Poland

Local Institution - 0017

Lodz, Łódź Voivodeship 93-513

Poland

ARENSIA Exploratory Medicine

Cluj-Napoca, Cluj 400015

Romania

Fundeni Clinical Institute

Bucharest, 022328

Romania

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña] 08041

Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de 28034

Spain