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New treatment option for Refractory Autoimmune Diseases
Official title A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07115745
What this study is testing
What is BMS-986515?
BMS-986515 is an investigational medicine, being studied as a potential treatment for refractory autoimmune diseases.
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 determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
- 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
- \- Systemic lupus erythematosus (SLE) population:.
- i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
- ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone...
- iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.
- iv) Participants must have active disease at screening.
You likely can't join if
- \- All participants:. i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history...
- SLE population:. i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
- IIM population:. i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
- SSc population:. i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under...
- RA population:. i) People who have additional autoimmune diseases along with RA.
- Other protocol-defined inclusion/exclusion criteria apply.
See the full eligibility criteria
- \- Systemic lupus erythematosus (SLE) population:.
- i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
- ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody.
- iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.
- iv) Participants must have active disease at screening.
- \- Inflammatory myopathy (IIM) population:.
- i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
- ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.
- iv) Evidence of active disease.
- \- Systemic sclerosis (SSc) population:.
- i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.
- ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease.
- \- Rheumatoid arthritis (RA) population:.
- i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease...
- \- All participants:. i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of...
- SLE population:. i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
- IIM population:. i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
- SSc population:. i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control. ii) Rapidly deteriorating SSc, or history of severe kidney...
- RA population:. i) People who have additional autoimmune diseases along with RA.
- Other protocol-defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Camperdown, New South Wales, Australia
- Brisbane, Queensland, Australia
- Clayton, Victoria, Australia
- Salvador, Estado de Bahia, Brazil
- Porto Alegre, Brazil
- São Paulo, Brazil
- Prague, Praha 5, Czechia
- Prague, Czechia
- Strasbourg, Alsace, France
- Lille, Nord, France
- Düsseldorf, North Rhine-Westphalia, Germany
- Kiel, Schleswig-Holstein, Germany
- Berlin, Germany
- Dresden, Germany
- Hamburg, Germany
- Ramat Gan, Central District, Israel
- Jerusalem, Israel
- Gdansk, Pomeranian Voivodeship, Poland
+ 8 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 Boston, Massachusetts, United States; Durham, North Carolina, United States; Camperdown, New South Wales, Australia; Brisbane, Queensland, Australia; Clayton, Victoria, Australia; Salvador, Estado de Bahia, Brazil and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.