Cyclophosphamide: Specified dose on specified days
Tocilizumab: Specified dose on specified days
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with treatment-emergent adverse events (TEAEs) — Up to 24 months post BMS-986515 infusion All participants
Number of participants with serious AEs (SAEs) — Up to 24 months post BMS-986515 infusion All participants
Number of participants with AEs of special interest (AESIs) — Up to 24 months post BMS-986515 infusion All participants
Number of participants with laboratory abnormalities — Up to 24 months post BMS-986515 infusion All participants
Number of participants with Dose-Limiting Toxicities (DLTs) — Up to 24 months post BMS-986515 infusion All participants
Number of participants with DLTs that occur during the DLT evaluation period — 28 days post-BMS-986515 infusion All participants
Trial sites (28)
Facility
City
Region
Status
Brigham And Womens Hospital
Boston
Massachusetts
Recruiting
Duke University
Durham
North Carolina
Recruiting
Local Institution - 0007
Camperdown
New South Wales
Withdrawn
Local Institution - 0008
Brisbane
Queensland
Withdrawn
Local Institution - 0013
Clayton
Victoria
Withdrawn
Local Institution - 0040
Salvador
Estado de Bahia
Not Yet Recruiting
Local Institution - 0039
Porto Alegre
Brazil
Not Yet Recruiting
Local Institution - 0038
São Paulo
Brazil
Not Yet Recruiting
Local Institution - 0004
Prague
Praha 5
Not Yet Recruiting
Revmatologicky ustav
Prague
Czechia
Recruiting
CHU Strasbourg-Hautepierre
Strasbourg
Alsace
Recruiting
Hopital Claude Huriez - CHU de Lille
Lille
Nord
Recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf
North Rhine-Westphalia
Recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel
Schleswig-Holstein
Recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin
Germany
Recruiting
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden
Germany
Recruiting
Local Institution - 0031
Hamburg
Germany
Withdrawn
Sheba Medical Center
Ramat Gan
Central District
Recruiting
Hadassah Medical Center
Jerusalem
Israel
Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk
Pomeranian Voivodeship
Recruiting
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom
Silesian Voivodeship
Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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