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New treatment option for Systemic Lupus Erythematosus
Official title A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
ClinicalTrials.gov ID: NCT05869955
What this study is testing
What is CC-97540?
CC-97540 is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as BMS-986353.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:. i) Fulfilling the 2019 European League Against Rheumatism (EULAR) / American...
- Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:. i) Fulfilling the 2017 EULAR/ACR classification criteria for probable or...
- IIM disease activity:. i) Severe/moderate muscle AND/OR skin involvement. ii) Proof of activity as documented by:. A. An active myositis-associated...
- Diagnosis of Systemic Sclerosis (SSc) defined as follows:. i) Fulfilling 2013 EULAR/ACR classification criteria for SSc. ii) Antinuclear Antibody...
You likely can't join if
- \- Diagnosis of drug-induced SLE rather than idiopathic SLE. \- Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Summit, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Dallas, Texas, United States
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.