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Clinical Trials in Germany / NCT05869955
Active, not recruiting Phase 1

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

NCT05869955 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2023-09-13
Last updated
2026-08-03

Condition(s) studied

Systemic Lupus ErythematosusIdiopathic Inflammatory MyopathySystemic SclerosisRheumatoid Arthritis

Investigational drug(s) / intervention(s)

CC-97540 →Fludarabine →Cyclophosphamide →Tocilizumab →

CC-97540: Specified dose on specified days

Fludarabine: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Tocilizumab: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
Local Institution - 0035 Aurora Colorado
Local Institution - 0024 Denver Colorado
Local Institution - 0006 Jacksonville Florida
Local Institution - 0056 Miami Florida
Local Institution - 0053 Chicago Illinois
Local Institution - 0038 Boston Massachusetts
Local Institution - 0033 Worcester Massachusetts
University of Massachusetts Chan Medical School Worcester Massachusetts
Local Institution - 0031 Ann Arbor Michigan
Local Institution - 0037 Detroit Michigan
Local Institution - 0022 Rochester Minnesota
Local Institution - 0010 St Louis Missouri
Local Institution - 0028 Omaha Nebraska
Local Institution - 0008 Summit New Jersey
Local Institution - 0002 New York New York
Local Institution - 0011 New York New York
Local Institution - 0007 New York New York
Local Institution - 0003 Chapel Hill North Carolina
Local Institution - 0005 Cleveland Ohio
Local Institution - 0036 Dallas Texas
Local Institution - 0029 Houston Texas
Local Institution - 0034 Houston Texas
Local Institution - 0004 Seattle Washington
Local Institution - 0057 Seattle Washington
Local Institution - 0058 Seattle Washington
Local Institution - 0019 Leuven Vlaams-Brabant
Local Institution - 0044 Pessac Aquitaine
Local Institution - 0015 Montpellier Hérault
Local Institution - 0016 Lille France
Local Institution - 0040 Nice France
Local Institution - 0018 Paris France
Local Institution - 0020 Rennes France
Local Institution - 0049 Würzburg Bavaria
Local Institution - 0042 Cologne North Rhine-Westphalia
Local Institution - 0041 Leipzig Saxony
Local Institution - 0045 Magdeburg Saxony-Anhalt
Local Institution - 0025 Berlin Germany
Local Institution - 0047 Düsseldorf Germany
Local Institution - 0017 Erlangen Germany
Local Institution - 0012 Rome Lazio

+ 6 more sites — see the full list on the official registry below.

On this site

📄 Actemra (tocilizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05869955 on ClinicalTrials.gov ↗ ← All trials in Germany