A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
NCT ID: NCT05869955
Last Updated: 2026-01-13
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
270 participants
INTERVENTIONAL
2023-09-13
2028-08-29
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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Administration of CC-97540
CC-97540
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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CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Tocilizumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
i) Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE.
ii) Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening.
\- SLE disease activity:.
i) Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system).
ii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.
* Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.
i) Fulfilling the 2017 EULAR/ACR classification criteria for probable or definite IIM.
ii) Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).
iii) Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.
* IIM disease activity:.
i) Severe/moderate muscle AND/OR skin involvement.
ii) Proof of activity as documented by:.
A. An active myositis-associated rash OR.
B. A recent muscle biopsy OR.
C. An elevated CK \> 3 times the upper limit of normal OR.
D. Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)
iii) Inadequate response to glucocorticoids and at least 2 of the following treatments used for at least 3 months: azathioprine, methotrexate, cyclosporin A, tacrolimus, MMF, cyclophosphamide, IVIG, JAK inhibitors, and rituximab.
* Diagnosis of Systemic Sclerosis (SSc) defined as follows:.
i) Fulfilling 2013 EULAR/ACR classification criteria for SSc.
ii) Antinuclear Antibody (ANA) positive at screening or prior to screening.
\- SSc disease activity:.
i) Participants diagnosed with diffuse cutaneous SSc OR diffuse or limited cutaneous SSc AND progressive ILD, AND.
ii) Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or intravenous immunoglobulins (IVIG).
\- Rheumatoid Arthritis (RA) disease activity:.
i) Minimum of 3 SJC and 3 TJC on a 66/68 joint count (SJC/TJC).
ii) OR participants diagnosed with progressive ILD (interstitial lung disease).
iii) AND Inadequate disease response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (DMARD) and as well as ≥ 2 DMARDs with different mechanisms of action from the categories biologic disease-modifying antirheumatic drug (bDMARDs) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) for a minimum of 3 months.
A. Participants qualifying on progressive ILD may have exhausted the therapies above OR have demonstrated inadequate disease response or intolerance to at least one of the following treatments used for at least 3 months: mycophenolate, tocilizumab, cyclophosphamide, rituximab, azathioprine, nintedinib, pirfenidone.
Exclusion Criteria
\- Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
* Present or recent clinically significant CNS pathology, within 12 months.
* IIM disease activity:.
i) Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.
ii) Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.
iii) Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index \> 7 cm on a 10 cm scale), permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement.
\- SSc disease activity:.
i) SSc related PAH requiring active treatment.
ii) Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.
iii) Prior scleroderma renal crisis.
\- RA disease activity:.
i) Prior history of or current inflammatory joint disease other than RA.
ii) Joint damage and/or deformity that may confound the investigator's ability to accurately assess disease activity.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb Services Unlimited Company
UNKNOWN
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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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Local Institution - 0048
New Haven, Connecticut, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Local Institution - 0053
Chicago, Illinois, United States
Local Institution - 0030
Baltimore, Maryland, United States
Local Institution - 0038
Boston, Massachusetts, United States
Local Institution - 0046
Boston, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Local Institution - 0028
Omaha, Nebraska, United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, United States
NYU Langone Health
New York, New York, United States
Local Institution - 0054
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Local Institution - 0055
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution - 0027
Columbus, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Local Institution - 0057
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0043
Strasbourg, Alsace, France
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, France
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, France
Hopital Claude Huriez - CHU de Lille
Lille, , France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, , France
Hôpital Saint-Louis
Paris, , France
Local Institution - 0052
Paris, , France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, , France
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy
Humanitas
Rozzano, Milano, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
H.R.U Málaga - Hospital General
Málaga, , 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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Melissa Griffith, Site 0035
Role: primary
Richard Nash, Site 0024
Role: primary
Vikas Majithia, Site 0006
Role: primary
Lazaros Lekakis, Site 0056
Role: primary
Site 0038
Role: primary
Jonathan Gerber, Site 0032
Role: primary
Roberto Caricchio, Site 0033
Role: primary
Monalisa Ghosh, Site 0031
Role: primary
Alireza Meysami, Site 0037
Role: primary
Uma Thanarajasingam, Site 0022
Role: primary
Alfred Kim, Site 0010
Role: primary
Neil Kramer, Site 0008
Role: primary
Amit Saxena, Site 0002
Role: primary
Margrit Wiesendanger, Site 0011
Role: primary
Anca Askanase, Site 0007
Role: primary
Saira Sheikh, Site 0003
Role: primary
Emily Littlejohn, Site 0005
Role: primary
Heidi Jacobe, Site 0036
Role: primary
Maureen Mayes, Site 0029
Role: primary
Chitra Hosing, Site 0034
Role: primary
Philip Mease, Site 0004
Role: primary
Site 0057
Role: primary
Alexandre Hirayama, Site 0058
Role: primary
Ellen De Langhe, Site 0019
Role: primary
Site 0043
Role: primary
Edouard Forcade, Site 0044
Role: primary
Jacques Morel, Site 0015
Role: primary
Ibrahim YAKOUB-AGHA, Site 0016
Role: primary
Nihal Martis, Site 0040
Role: primary
Dominique Farge, Site 0018
Role: primary
Roch Houot, Site 0020
Role: primary
Marc Schmalzing, Site 0049
Role: primary
Philipp Koehler, Site 0042
Role: primary
Vladan Vucinic, Site 0041
Role: primary
Dimitrios Mougiakakos, Site 0045
Role: primary
David Simon, Site 0025
Role: primary
Joerg Distler, Site 0047
Role: primary
Georg Schett, Site 0017
Role: primary
MARIA ANTONIETTA D'AGOSTINO, Site 0012
Role: primary
Armando Santoro, Site 0023
Role: primary
JOSEFINA CORTES-HERNANDEZ, Site 0014
Role: primary
Ricardo Blanco, Site 0013
Role: primary
Ignasi Rodriguez-Pintó, Site 0021
Role: primary
ALEJANDRO ESCUDERO, Site 0050
Role: primary
Antonio Fernandez Nebro, Site 0039
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-503823-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA061-1001
Identifier Type: -
Identifier Source: org_study_id
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