Recruiting

BMS-986515 CAR T Cells for Severe Refractory Autoimmune Diseases

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What is being tested

BMS-986515

+ Fludarabine

+ Cyclophosphamide

GeneticDrug
Who is being recruted

Urogenital Diseases+28

+ Arthritis

+ Arthritis, Rheumatoid

Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 4, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the safety and effectiveness of a new treatment called BMS-986515, which is a type of cell therapy made from healthy donor cells designed to target CD19 on immune cells. It is specifically for people with severe autoimmune diseases that have not responded to other treatments. Autoimmune diseases occur when the body's immune system mistakenly attacks its own tissues. This research is important because it could offer a new hope for patients who have exhausted existing treatment options and continue to suffer from symptoms of their disease. Participants in this study will receive the BMS-986515 therapy, which involves using specially modified cells administered to them. Researchers will carefully monitor participants to see how their bodies react to the treatment, looking for any side effects and determining the best dosage to use. The study will not only check how safe the treatment is but also observe any signs of improvement in the participants' conditions. The ultimate goal is to find a safe and effective dose that could potentially alleviate symptoms and improve the quality of life for those affected by these challenging diseases.

Official TitleA 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 
NCT07115745
Principal SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

125 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesDermatomyositisFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesJoint DiseasesKidney DiseasesLupus Erythematosus, SystemicLupus NephritisMuscular DiseasesMusculoskeletal DiseasesMyositisNephritisNervous System DiseasesNeuromuscular DiseasesPathologic ProcessesRheumatic DiseasesScleroderma, SystemicSclerosisSkin DiseasesPathological Conditions, Signs and SymptomsUrologic DiseasesPolymyositisSkin and Connective Tissue DiseasesScleroderma, DiffuseFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

15 inclusion criteria required to participate
Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
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.
Inadequate response or intolerance to steroids and immunosuppressive therapies.
Participants must have active disease at screening.
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16 exclusion criteria prevent from participating
Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
Participants who have other forms of myopathies other than IIM.
Severe muscle damage.
People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Recruiting

Revmatologicky ustav

Prague, CzechiaSee the location
Recruiting

CHU Strasbourg-Hautepierre

Strasbourg, France
Recruiting

Hopital Claude Huriez - CHU de Lille

Lille, France
Recruiting

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany
Recruiting
29 Study Centers