A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
NCT ID: NCT07115745
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
125 participants
INTERVENTIONAL
2025-09-04
2030-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMS-986515 Administration
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0041
Boston, Massachusetts, United States
Local Institution - 0037
Durham, North Carolina, United States
Local Institution - 0033
Seattle, Washington, United States
Local Institution - 0007
Camperdown, New South Wales, Australia
Local Institution - 0008
Brisbane, Queensland, Australia
Local Institution - 0013
Clayton, Victoria, Australia
Local Institution - 0040
Salvador, Estado de Bahia, Brazil
Local Institution - 0039
Porto Alegre, , Brazil
Local Institution - 0038
São Paulo, , Brazil
Local Institution - 0004
Prague, Praha 5, Czechia
Revmatologicky ustav
Prague, , Czechia
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, France
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
Local Institution - 0023
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Local Institution - 0031
Hamburg, , Germany
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, , Israel
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0017
Lodz, Łódź Voivodeship, Poland
ARENSIA Exploratory Medicine
Cluj-Napoca, Cluj, Romania
Fundeni Clinical Institute
Bucharest, , Romania
Local Institution - 0011
Barcelona, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0041
Role: primary
Site 0037
Role: primary
Site 0033
Role: primary
Site 0007
Role: primary
Site 0008
Role: primary
Site 0013
Role: primary
Site 0040
Role: primary
Site 0039
Role: primary
Site 0038
Role: primary
Site 0004
Role: primary
Ladislav Senolt, Site 0001
Role: primary
Marc SCHERLINGER, Site 0005
Role: primary
Ibrahim YAKOUB-AGHA, Site 0006
Role: primary
Site 0023
Role: primary
Catrin Meyer, Site 0021
Role: primary
David Simon, Site 0022
Role: primary
Anne-Kathrin Tausche-Wunderlich, Site 0029
Role: primary
Site 0031
Role: primary
Merav Lidar, Site 0015
Role: primary
Dror Mevorach, Site 0016
Role: primary
Anna Wojteczek, Site 0019
Role: primary
Aleksandra Zon-Giebel, Site 0020
Role: primary
Sebastian Giebel, Site 0032
Role: primary
Site 0017
Role: primary
Ciprian Tomuleasa, Site 0003
Role: primary
Mihai Abobului, Site 0018
Role: primary
Site 0011
Role: primary
Ivan Castellvi Barranco, Site 0009
Role: primary
Maria Jesus Villanueva, Site 0010
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-517681-41
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1308-9273
Identifier Type: OTHER
Identifier Source: secondary_id
IM060-0001
Identifier Type: -
Identifier Source: org_study_id
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