A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ \- 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.

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Colorado Blood Cancer Institute
RECRUITING
Denver
Connecticut
Local Institution - 0048
WITHDRAWN
New Haven
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
University of Miami Hospital and Clinics, Sylvester Cancer Center
RECRUITING
Miami
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Massachusetts
Local Institution - 0038
NOT_YET_RECRUITING
Boston
Local Institution - 0046
WITHDRAWN
Boston
University of Massachusetts Chan Medical School
RECRUITING
Worcester
University of Massachusetts Chan Medical School
NOT_YET_RECRUITING
Worcester
Maryland
Local Institution - 0030
WITHDRAWN
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Medical Center - New Center One
RECRUITING
Detroit
Minnesota
Mayo Clinic in Rochester, Minnesota
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
The University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Nebraska
Local Institution - 0028
COMPLETED
Omaha
New Jersey
Atlantic Health System Overlook Medical Center
RECRUITING
Summit
New York
Columbia University Irving Medical Center
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Local Institution - 0054
WITHDRAWN
New York
Local Institution - 0055
WITHDRAWN
New York
NYU Langone Health
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Local Institution - 0027
WITHDRAWN
Columbus
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Local Institution - 0057
NOT_YET_RECRUITING
Seattle
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
France
Hopital Claude Huriez - CHU de Lille
RECRUITING
Lille
CHU Montpellier Lapeyronie Hospital
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
RECRUITING
Nice
Hôpital Saint-Louis
RECRUITING
Paris
Local Institution - 0052
WITHDRAWN
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Local Institution - 0043
NOT_YET_RECRUITING
Strasbourg
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
RECRUITING
Berlin
Universitaetsklinikum Koeln
RECRUITING
Cologne
Universitaetsklinikum Duesseldorf
RECRUITING
Düsseldorf
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitaetsklinikum Magdeburg
RECRUITING
Magdeburg
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING
Rome
Humanitas
RECRUITING
Rozzano
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
H.R.U Málaga - Hospital General
RECRUITING
Málaga
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2028-08-29
Participants
Target number of participants: 270
Treatments
Experimental: Administration of CC-97540
Sponsors
Collaborators: Bristol-Myers Squibb Services Unlimited Company
Leads: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

This content was sourced from clinicaltrials.gov