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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 (MSA), associated antibody (MAA), or ANA at screening or prior to screening.

- IIM disease activity.

i) Severe 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, leflunomide, IVIG, 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). 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.

- Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05869955
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Belgium, France, Germany, Italy, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Administration of CC-97540

Interventions

Drug: - CC-97540

Specified dose on specified days

Drug: - Fludarabine

Specified dose on specified days

Drug: - Cyclophosphamide

Specified dose on specified days

Drug: - Tocilizumab

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

Site Contact

Melissa Griffith, Site 0035

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