Engineered immune cells take on lupus and other autoimmune diseases

NCT ID NCT05869955

Disease control Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new treatment called CC-97540, which uses a patient's own immune cells modified to target and destroy faulty immune cells. It is for people with severe forms of lupus, myositis, scleroderma, or rheumatoid arthritis that have not improved with standard treatments. The main goals are to check safety and find the right dose, while also looking for signs that the disease gets better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: CC-97540 (a type of CAR T cell therapy that targets CD19 on immune cells)
What this could lead to: If it works, this could point toward a new treatment option for people with severe autoimmune diseases that haven't responded to other therapies.
What could go wrong: This is an early Phase 1 trial focused on safety, so it's too soon to know if it works. CAR T therapy can cause serious side effects like cytokine release syndrome and infections.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic inflammatory myopathy myositis disease rheumatoid arthritis systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic inflammatory myopathy Rheumatoid arthritis Systemic lupus erythematosus Systemic sclerosis

Contacts and locations

Locations

Local Institution - 0002

New York, New York, 10016, United States
Local Institution - 0003

Chapel Hill, North Carolina, 27599, United States
Local Institution - 0004

Seattle, Washington, 98104, United States
Local Institution - 0005

Cleveland, Ohio, 44195, United States
Local Institution - 0006

Jacksonville, Florida, 32224, United States
Local Institution - 0007

New York, New York, 10032, United States
Local Institution - 0008

Summit, New Jersey, 07901, United States
Local Institution - 0010

St Louis, Missouri, 63110, United States
Local Institution - 0011

New York, New York, 10029, United States
Local Institution - 0012

Rome, Lazio, 00168, Italy
Local Institution - 0013

Santander, Cantabria, 39008, Spain
Local Institution - 0014

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0015

Montpellier, Hérault, 34295, France
Local Institution - 0016

Lille, 59037, France
Local Institution - 0017

Erlangen, 91054, Germany
Local Institution - 0018

Paris, 75010, France
Local Institution - 0019

Leuven, Vlaams-Brabant, 3000, Belgium
Local Institution - 0020

Rennes, 35033, France
Local Institution - 0021

Barcelona, Catalunya [Cataluña], 08036, Spain
Local Institution - 0022

Rochester, Minnesota, 55905, United States
Local Institution - 0023

Rozzano, Milano, 20089, Italy
Local Institution - 0024

Denver, Colorado, 80218, United States
Local Institution - 0025

Berlin, 10117, Germany
Local Institution - 0028

Omaha, Nebraska, 68198, United States
Local Institution - 0029

Houston, Texas, 77030, United States
Local Institution - 0031

Ann Arbor, Michigan, 48109-2800, United States
Local Institution - 0033

Worcester, Massachusetts, 01655, United States
Local Institution - 0034

Houston, Texas, 77030, United States
Local Institution - 0035

Aurora, Colorado, 80045, United States
Local Institution - 0036

Dallas, Texas, 75390, United States
Local Institution - 0037

Detroit, Michigan, 48202, United States
Local Institution - 0038

Boston, Massachusetts, 02115, United States
Local Institution - 0039

Málaga, 29011, Spain
Local Institution - 0040

Nice, 06202, France
Local Institution - 0041

Leipzig, Saxony, 04103, Germany
Local Institution - 0042

Cologne, North Rhine-Westphalia, 50937, Germany
Local Institution - 0044

Pessac, Aquitaine, 33600, France
Local Institution - 0045

Magdeburg, Saxony-Anhalt, 39120, Germany
Local Institution - 0047

Düsseldorf, 40225, Germany
Local Institution - 0049

Würzburg, Bavaria, 97080, Germany
Local Institution - 0050

Córdoba, 14004, Spain
Local Institution - 0053

Chicago, Illinois, 60612, United States
Local Institution - 0056

Miami, Florida, 33136, United States
Local Institution - 0057

Seattle, Washington, 98105, United States
Local Institution - 0058

Seattle, Washington, 98109, United States
University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

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