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Clinical Trials in Germany / NCT07115745
Recruiting Phase 1

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

NCT07115745 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2025-09-04
Last updated
2026-07-14

Condition(s) studied

Refractory Autoimmune Diseases

Investigational drug(s) / intervention(s)

BMS-986515Fludarabine →Cyclophosphamide →Tocilizumab →

BMS-986515: Specified dose on specified days

Fludarabine: Specified dose on specified days

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)

Trial sites (28)

FacilityCityRegionStatus
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 Gliwice Silesian Voivodeship Recruiting
Local Institution - 0017 Lodz Łódź Voivodeship Withdrawn
ARENSIA Exploratory Medicine Cluj-Napoca Cluj Recruiting
Fundeni Clinical Institute Bucharest Romania Recruiting
Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona] Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Catalunya [Cataluña] Recruiting
Hospital Universitario Ramón y Cajal Madrid Madrid, Comunidad de Recruiting

On this site

📄 Actemra (tocilizumab) drug profile →

More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in Germany

Official registry record

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.

View NCT07115745 on ClinicalTrials.gov ↗ ← All trials in Germany