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

NCT05869955 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CA061-10012023-503823-24
• Study Type: interventional
• Target: 270
• Locations: 6 countries
• Sites: 54

Brief 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).

Conditions

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

Keywords

CC-97540; BMS-986353

Outcome Measures

Primary Outcomes (6)

• Number of participants with treatment-emergent adverse events (AEs) in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with serious AEs (SAEs) in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with AEs of special interest (AESI) in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with laboratory abnormalities in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with Dose Limiting Toxicities (DLT) in each indication.

  Up to 2 years after CC-97540 infusion

• Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.

  Up to 2 years after CC-97540 infusion

Secondary Outcomes (16)

• Proportion of participants achieving definition of remission in SLE (DORIS) remission

  At week 24

• Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)

  At week 24

• Change in proteinuria measured by urine protein creatinine ratio (UPCR)

  At week 24

• Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)

  At week 24

• Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response

  At Week 24

Study Arms (1)

Administration of CC-97540

EXPERIMENTAL

Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab

Interventions

Fludarabine DRUG

Specified dose on specified days

Administration of CC-97540

Cyclophosphamide DRUG

Specified dose on specified days

Administration of CC-97540

Tocilizumab DRUG

Specified dose on specified days

Administration of CC-97540

CC-97540 DRUG

Specified dose on specified days

Also known as: BMS-986353

Administration of CC-97540

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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:.
• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb Services Unlimited Company: collaborator
• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (54)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Local Institution - 0048

New Haven, Connecticut, 06520, United States

WITHDRAWN

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Local Institution - 0053

Chicago, Illinois, 60612, United States

ACTIVE NOT RECRUITING

Local Institution - 0030

Baltimore, Maryland, 21287, United States

WITHDRAWN

Local Institution - 0038

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Local Institution - 0046

Boston, Massachusetts, 02115, United States

WITHDRAWN

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

NOT YET RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-2800, United States

RECRUITING

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Local Institution - 0028

Omaha, Nebraska, 68198, United States

COMPLETED

Atlantic Health System Overlook Medical Center

Summit, New Jersey, 07901, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Local Institution - 0054

New York, New York, 10021, United States

WITHDRAWN

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Local Institution - 0055

New York, New York, 10065, United States

WITHDRAWN

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Local Institution - 0027

Columbus, Ohio, 43203, United States

WITHDRAWN

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Local Institution - 0057

Seattle, Washington, 98105, United States

NOT YET RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Local Institution - 0043

Strasbourg, Alsace, 67098, France

WITHDRAWN

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine, 33600, France

RECRUITING

CHU Montpellier Lapeyronie Hospital

Montpellier, Hérault, 34295, France

RECRUITING

Hopital Claude Huriez - CHU de Lille

Lille, 59037, France

RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 06202, France

RECRUITING

Hôpital Saint-Louis

Paris, 75010, France

RECRUITING

Local Institution - 0052

Paris, 75679, France

WITHDRAWN

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

RECRUITING

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

RECRUITING

Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

H.R.U Málaga - Hospital General

Málaga, 29011, Spain

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Myositis; Scleroderma, Systemic; Arthritis, Rheumatoid

Interventions

fludarabine; Cyclophosphamide; tocilizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 23, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): August 29, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (5); FR (8); US (31); BE (1); IT (2); DE (7)