A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

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

  • Systemic Lupus Erythematosus
  • Idiopathic Inflammatory Myopathy
  • Systemic Sclerosis
  • Rheumatoid Arthritis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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/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

  • 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. - 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. - 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 5412347, Colorado 5417618 80045
Contact:
Melissa Griffith, Site 0035
720-848-7700

Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218
Contact:
Richard Nash, Site 0024
303-981-2305

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224
Contact:
Vikas Majithia, Site 0006
904-953-2000

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
Contact:
Lazaros Lekakis, Site 0056
305-748-0641

University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Roberto Caricchio, Site 0033
267-968-7826

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109-2800
Contact:
Monalisa Ghosh, Site 0031
734-936-4000

Henry Ford Medical Center - New Center One
Detroit 4990729, Michigan 5001836 48202
Contact:
Alireza Meysami, Site 0037
313-916-9328

Mayo Clinic in Rochester, Minnesota
Rochester 5043473, Minnesota 5037779 55905
Contact:
Uma Thanarajasingam, Site 0022
507-422-9855

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Alfred Kim, Site 0010
314-326-4785

Atlantic Health System Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901
Contact:
Neil Kramer, Site 0008
646-734-2774

NYU Langone Health
New York 5128581, New York 5128638 10016
Contact:
Amit Saxena, Site 0002
646-501-7387

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Margrit Wiesendanger, Site 0011
646-285-7881

Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
Contact:
Anca Askanase, Site 0007
555-555-5555

The University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Saira Sheikh, Site 0003
919-966-0545

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Emily Littlejohn, Site 0005
216-445-5559

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
Contact:
Heidi Jacobe, Site 0036
214-648-3348

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Maureen Mayes, Site 0029
713-500-6905

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Chitra Hosing, Site 0034
713-745-3219

Swedish Medical Center
Seattle 5809844, Washington 5815135 98104
Contact:
Philip Mease, Site 0004
206-386-2000

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
Contact:
Alexandre Hirayama, Site 0058
206-606-1024

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

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center