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Purpose

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:. 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 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).

Exclusion Criteria

  • Diagnosis of drug-induced SLE rather than idiopathic SLE. - 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. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of CC-97540
  • Drug: CC-97540
    Specified dose on specified days
    Other names:
    • BMS-986353
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days
  • Drug: Tocilizumab
    Specified dose on specified days

Recruiting Locations

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
Melissa Griffith, Site 0035
720-848-7700

Colorado Blood Cancer Institute
Denver, Colorado 80218
Contact:
Richard Nash, Site 0024
303-981-2305

Mayo Clinic in Florida
Jacksonville, Florida 32224
Contact:
Vikas Majithia, Site 0006
904-953-2000

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida 33136
Contact:
Lazaros Lekakis, Site 0056
305-748-0641

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
Contact:
Roberto Caricchio, Site 0033
267-968-7826

University of Michigan
Ann Arbor, Michigan 48109-2800
Contact:
Monalisa Ghosh, Site 0031
734-936-4000

Henry Ford Medical Center - New Center One
Detroit, Michigan 48202
Contact:
Alireza Meysami, Site 0037
313-622-4386

Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Contact:
Uma Thanarajasingam, Site 0022
507-422-9855

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Alfred Kim, Site 0010
314-326-4785

University Of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Michael Feely, Site 0028
402-391-3800

Atlantic Health System Overlook Medical Center
Summit, New Jersey 07901
Contact:
Neil Kramer, Site 0008
646-734-2774

NYU Langone Health
New York, New York 10016
Contact:
Amit Saxena, Site 0002
646-501-7387

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Margrit Wiesendanger, Site 0011
646-285-7881

Columbia University Irving Medical Center
New York, New York 10032
Contact:
Anca Askanase, Site 0007
555-555-5555

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Saira Sheikh, Site 0003
919-966-0545

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Emily Littlejohn, Site 0005
216-445-5559

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
Heidi Jacobe, Site 0036
214-648-3348

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Maureen Mayes, Site 0029
713-500-6905

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Chitra Hosing, Site 0034
713-745-3219

Swedish Medical Center
Seattle, Washington 98104
Contact:
Philip Mease, Site 0004
206-386-2000

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Alexandre Vinaud Hirayama, Site 0058
206-667-6909

More Details

NCT ID
NCT05869955
Status
Recruiting
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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