RecruitingPhase 1

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986515, a CAR T-cell treatment made from a healthy donor’s immune cells. It checks safety, side effects, the best dose, and early signs that it works in people with severe autoimmune diseases that are hard to treat. These are diseases in which the immune system attacks the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have one of the diseases below and meet its listed medical diagnosis rules.
  • Lupus (SLE): Active disease, with steroids and medicines that weaken the immune system not helping enough or causing side effects you cannot tolerate.
  • Lupus: A positive test for at least one listed antibody: anti-nuclear, anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm. Antibodies are proteins made by the immune system.
  • Inflammatory myopathy (IIM, a disease that inflames muscles): Severe, active disease that has not improved enough with steroids and medicines that weaken the immune system.
  • Systemic sclerosis (SSc, a disease that hardens skin and can affect organs): Worsening skin disease, lung tissue disease, or both. Past treatments must not have helped enough or caused side effects you cannot tolerate.
  • Rheumatoid arthritis (RA, a disease that inflames joints): Hard-to-treat disease that is active at screening and the baseline visit. Standard treatment must not have helped enough or caused side effects you cannot tolerate.
  • Other study rules also apply.

Who can't join

  • Another autoimmune disease that affects the whole body, or lupus caused by medicines.
  • Pregnant or breastfeeding.
  • Active hepatitis B, hepatitis C, or HIV; or an active or uncontrolled infection.
  • A history of cancer, or past CAR T-cell treatment.
  • Certain heart or blood vessel conditions within 6 months before screening.
  • Major lung problems, organs that do not work well enough, or active, serious brain or spinal cord disorders.
  • For inflammatory myopathy: Another type of muscle disease or severe muscle damage.
  • For systemic sclerosis: High blood pressure in the lung arteries caused by the disease that needs regular treatment, quickly worsening disease, or a history of severe kidney disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 response or intolerance to standard of care therapy. Exclusion Criteria \- 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 certain cardiovascular conditions within 6 months prior to screening. vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders. * 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 disease. * RA population:. i) People who have additional autoimmune diseases along with RA. * Other protocol-defined inclusion/exclusion criteria apply.

Study sites (2)

MA

NC