ClinicalTrials.gov record NCT07115745

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationAustralia, Brazil, Czechia, France, Germany, Israel, Poland, Romania, Spain, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 1, open-label study evaluates BMS-986515, a healthy-donor allogeneic CD19-targeted CAR T-cell product, in people with severe, refractory autoimmune diseases (examples: SLE, inflammatory myopathies, systemic sclerosis, and RA). Participants receive preparatory chemotherapy (fludarabine and cyclophosphamide), may receive tocilizumab as specified, then an infusion of BMS-986515 and are followed for safety for up to 24 months; most disease-specific efficacy assessments are through Week 24. The main goals are to find safe dose levels and collect early information on effects.

What it is studying. The study is testing BMS-986515 (healthy-donor CD19-targeted CAR T cells) to determine safety, tolerability, the best dose, and early signs of effect in people with severe, treatment-refractory autoimmune diseases.

What the researchers hope to learn. Scientifically, the trial aims to determine safety and tolerability (including serious adverse events and dose-limiting toxicities), identify optimal dosing, characterize pharmacokinetics (Cmax, AUC, Tmax) and anti-drug immune responses, and gather early data on disease-specific measures (for example renal, skin, muscle, and function scores at Week 24).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Fludarabine
  • Cyclophosphamide
  • Tocilizumab
Genetic
  • BMS-986515

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive lymphodepleting drugs (fludarabine and cyclophosphamide), then an infusion of the investigational allogeneic CD19 CAR T product (BMS-986515); tocilizumab may be given per protocol. Early safety monitoring includes a dose‑limiting toxicity (DLT) evaluation period (first 28 days) with frequent clinic visits, medical exams, and blood tests. Disease activity assessments and questionnaires relevant to each condition (for example lupus, myositis, scleroderma, or RA measures) will be done, and participants are followed for safety and lab monitoring for up to about 24 months after infusion. Specific visit schedules and other procedures are defined in the study protocol.

How the study is structured. Phase 1 interventional trial, open-label and single-group: all participants receive lymphodepleting drugs (fludarabine and cyclophosphamide), may receive tocilizumab as specified, and then receive an infusion of the BMS-986515 CAR T product. Participants are monitored without masking for adverse events, lab changes, drug levels, immune response, and disease-specific outcomes over follow-up of up to 24 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Australia, Brazil, Czechia, France, Germany, Israel, Poland, Romania, Spain, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 4, 2025
Primary completion
Mar 15, 2029 (estimated)
Study completion
Aug 16, 2030 (estimated)
Target enrollment
125 participants (estimated)
Last updated on registry
Jul 14, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (28)

  • Brigham And Womens HospitalRecruiting

    Boston, Massachusetts, 02115 · United States

  • Duke UniversityRecruiting

    Durham, North Carolina, 27705-2771 · United States

  • Local Institution - 0007Withdrawn

    Camperdown, New South Wales, 2050 · Australia

  • Local Institution - 0008Withdrawn

    Brisbane, Queensland, 4029 · Australia

  • Local Institution - 0013Withdrawn

    Clayton, Victoria, 3168 · Australia

  • Local Institution - 0040Not Yet Recruiting

    Salvador, Estado de Bahia, 41253-190 · Brazil

    • Site 0040
  • Local Institution - 0039Not Yet Recruiting

    Porto Alegre, 0 · Brazil

    • Site 0039
  • Local Institution - 0038Not Yet Recruiting

    São Paulo, 01508-010 · Brazil

    • Site 0038
  • Local Institution - 0004Not Yet Recruiting

    Prague, Praha 5, 150 06 · Czechia

    • Site 0004
  • Revmatologicky ustavRecruiting

    Prague, 12850 · Czechia

Terms used on this page · explanations by MedicalUpdates.ai

refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
CAR-T
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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