Recruiting

BMS-986515 CAR T Cells for Severe Refractory Autoimmune Diseases

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What is being tested

BMS-986515

+ Fludarabine
+ Cyclophosphamide
Genetic
Drug
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, 2025Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Dermatomyositis
Female Urogenital Diseases and Pregnancy Complications
Glomerulonephritis
Immune System Diseases
Joint Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Lupus Nephritis
Muscular Diseases
Musculoskeletal Diseases
Myositis
Nephritis
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases
Scleroderma, Systemic
Sclerosis
Skin Diseases
Pathological Conditions, Signs and Symptoms
Urologic Diseases
Polymyositis
Skin and Connective Tissue Diseases
Scleroderma, Diffuse
Female Urogenital Diseases
Male 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

Specified dose on specified days

Specified dose on specified days

Specified dose on specified days

Specified dose on specified days
Study Objectives
Primary Objectives

All participants

All participants

All participants

All participants

All participants

All participants
Secondary Objectives

All participants

All participants

All participants

All participants

Systemic lupus erythematosus (SLE) participants

SLE participants

SLE participants

SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants

Inflammatory myopathy (IIM) participants

IIM participants

Dermatomyositis (DM) participants only

SSc participants

SSc participants

RA participants

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 ustavPrague, CzechiaSee the location
Recruiting
CHU Strasbourg-HautepierreStrasbourg, France
Recruiting
Hopital Claude Huriez - CHU de LilleLille, France
Recruiting
Universitaetsklinikum Schleswig-Holstein Campus KielKiel, Germany
Recruiting
29 Study Centers
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