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

Running, not enrolling · Phase 1

Conditions studied: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT05869955

Run by

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

People needed

270

Starts

2023-09-13

Expected to finish

2028-08-29

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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:.

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:.
• 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.

Where it is running

• Local Institution - 0035 — Aurora, Colorado, United States
• Local Institution - 0024 — Denver, Colorado, United States
• Local Institution - 0006 — Jacksonville, Florida, United States
• Local Institution - 0056 — Miami, Florida, United States
• Local Institution - 0053 — Chicago, Illinois, United States
• Local Institution - 0038 — Boston, Massachusetts, United States
• Local Institution - 0033 — Worcester, Massachusetts, United States
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
• Local Institution - 0031 — Ann Arbor, Michigan, United States
• Local Institution - 0037 — Detroit, Michigan, United States
• Local Institution - 0022 — Rochester, Minnesota, United States
• Local Institution - 0010 — St Louis, Missouri, United States
• Local Institution - 0028 — Omaha, Nebraska, United States
• Local Institution - 0008 — Summit, New Jersey, United States
• Local Institution - 0002 — New York, New York, United States
• Local Institution - 0011 — New York, New York, United States
• Local Institution - 0007 — New York, New York, United States
• Local Institution - 0003 — Chapel Hill, North Carolina, United States
• Local Institution - 0005 — Cleveland, Ohio, United States
• Local Institution - 0036 — Dallas, Texas, United States
• Local Institution - 0029 — Houston, Texas, United States
• Local Institution - 0034 — Houston, Texas, United States
• Local Institution - 0004 — Seattle, Washington, United States
• Local Institution - 0057 — Seattle, Washington, United States
• Local Institution - 0058 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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