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

NCT ID
NCT07115745
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Conditions
Refractory Autoimmune Diseases

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 125 participants (Estimated).

What is being studied

  • Genetic: BMS-986515
  • Drug: Cyclophosphamide
  • Intervention: Cyclophosphamide
  • Intervention: fludarabine
  • Drug: Fludarabine
  • Intervention: Hydrocarbons
  • Intervention: Hydrocarbons, Halogenated
  • Intervention: Mustard Compounds
  • Intervention: Nitrogen Mustard Compounds
  • Intervention: Organic Chemicals
  • Intervention: Organophosphorus Compounds
  • Intervention: Phosphoramide Mustards
  • Intervention: Phosphoramides
  • Intervention: tocilizumab
  • Drug: Tocilizumab

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 locations

28 study locations are listed.

Recruiting site status is explicitly provided for 28 locations; 19 are listed as Recruiting.

Countries: Australia, Brazil, Czechia, France, Germany, Israel, Poland, Romania, Spain, United States

  • New South Wales, Australia: 1
  • Queensland, Australia: 1
  • Victoria, Australia: 1
  • Estado de Bahia, Brazil: 1
  • Praha 5, Czechia: 1
  • Alsace, France: 1
  • Nord, France: 1
  • North Rhine-Westphalia, Germany: 1
  • Schleswig-Holstein, Germany: 1
  • Central District, Israel: 1
  • Łódź Voivodeship, Poland: 1
  • Pomeranian Voivodeship, Poland: 1
  • Silesian Voivodeship, Poland: 2
  • Cluj, Romania: 1
  • Barcelona [Barcelona], Spain: 1
  • Catalunya [Cataluña], Spain: 1
  • Madrid, Comunidad de, Spain: 1
  • Massachusetts, United States: 1
  • North Carolina, United States: 1

Sample of listed locations

  • Revmatologicky ustav — Prague, 12850, Czechia — Recruiting
  • CHU Strasbourg-Hautepierre — Strasbourg, Alsace, 67098, France — Recruiting
  • Hopital Claude Huriez - CHU de Lille — Lille, Nord, 59037, France — Recruiting
  • Universitaetsklinikum Duesseldorf — Düsseldorf, North Rhine-Westphalia, 40225, Germany — Recruiting
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel — Kiel, Schleswig-Holstein, 24105, Germany — Recruiting
  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin — Berlin, 10117, Germany — Recruiting
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, 01307, Germany — Recruiting
  • Sheba Medical Center — Ramat Gan, Central District, 5262100, Israel — Recruiting
  • Hadassah Medical Center — Jerusalem, 9112001, Israel — Recruiting
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Pomeranian Voivodeship, 80-952, Poland — Recruiting
  • Szpital Specjalistyczny nr 1 w Bytomiu — Bytom, Silesian Voivodeship, 41-902, Poland — Recruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach — Gliwice, Silesian Voivodeship, 44-100, Poland — Recruiting
  • ARENSIA Exploratory Medicine — Cluj-Napoca, Cluj, 400015, Romania — Recruiting
  • Fundeni Clinical Institute — Bucharest, 022328, Romania — Recruiting
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], 08035, Spain — Recruiting
  • Hospital de la Santa Creu i Sant Pau — Barcelona, Catalunya [Cataluña], 08041, Spain — Recruiting
  • Hospital Universitario Ramón y Cajal — Madrid, Madrid, Comunidad de, 28034, Spain — Recruiting
  • Brigham And Womens Hospital — Boston, Massachusetts, 02115, United States — Recruiting
  • Duke University — Durham, North Carolina, 27705-2771, United States — Recruiting
  • Local Institution - 0007 — Camperdown, New South Wales, 2050, Australia — Withdrawn
  • Local Institution - 0008 — Brisbane, Queensland, 4029, Australia — Withdrawn
  • Local Institution - 0013 — Clayton, Victoria, 3168, Australia — Withdrawn
  • Local Institution - 0040 — Salvador, Estado de Bahia, 41253-190, Brazil — Not yet recruiting
  • Local Institution - 0039 — Porto Alegre, 0, Brazil — Not yet recruiting
  • Local Institution - 0038 — São Paulo, 01508-010, Brazil — Not yet recruiting

Study details

Start date
September 4, 2025
Primary completion date
March 15, 2029
Completion date
August 16, 2030
First posted
August 11, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07115745
Registry last updated
July 14, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07115745 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Clinical trial FAQ