Clinical trial 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?
an investigational allogeneic CD19‑targeted CAR‑T cell therapy being studied for severe, refractory autoimmune diseases is designed to recognize and destroy CD19‑expressing immune cells that may drive autoimmunity
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
- This study is testing whether a new cell therapy is safe and works. It also looks for the best amount to give.
- Who it's for
- You may be able to join if you have a severe autoimmune disease that has not responded to other treatments.
- What's involved
- You would get a one-time infusion of cells from a healthy donor. These cells are designed to target a specific type of immune cell.
- Time commitment
- The study involves visits to check your health and how the treatment works over time.
- 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.
- 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.
- \- 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.
- 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.
- 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 is enrolling
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Prague, Czechia
- Strasbourg, Alsace, France
- Lille, Nord, France
- Düsseldorf, North Rhine-Westphalia, Germany
- Kiel, Schleswig-Holstein, Germany
- Berlin, Germany
- Dresden, Germany
- Ramat Gan, Central District, Israel
- Jerusalem, Israel
- Gdansk, Pomeranian Voivodeship, Poland
- Bytom, Silesian Voivodeship, Poland
- Gliwice, Silesian Voivodeship, Poland
- Cluj-Napoca, Cluj, Romania
- Bucharest, Romania
- Barcelona, Barcelona [Barcelona], Spain
- Barcelona, Catalunya [Cataluña], Spain
- Madrid, Madrid, Comunidad de, Spain
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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Durham, North Carolina, United States; Prague, Czechia; Strasbourg, Alsace, France; Lille, Nord, France; Düsseldorf, North Rhine-Westphalia, Germany and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.