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

RECRUITINGPHASE1

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

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)

NCT05869955•Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+19 more criteria

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.
+5 more criteria

Locations (54)

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

Key Dates

Start Date

September 13, 2023

Primary Completion Date

August 29, 2028

Completion Date

August 29, 2028

Last Updated

January 13, 2026

Enrollment

270

ESTIMATED participants

Conditions

Systemic Lupus ErythematosusIdiopathic Inflammatory MyopathySystemic SclerosisRheumatoid Arthritis

Interventions

CC-97540

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Tocilizumab

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

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

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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