BMS-986515 CAR T Cells for Severe Refractory Autoimmune Diseases

What is being tested

BMS-986515

+ Fludarabine

+ Cyclophosphamide

Genetic

Drug

Who is being recruted

Refractory Autoimmune Diseases

Over 18 Years

+32 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.com

Last updated: November 4, 2025

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

Principal SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Last updated: November 4, 2025

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

Refractory Autoimmune Diseases

Criteria

15 inclusion criteria required to participate

iii) Rheumatoid arthritis disease activity at screening and baseline visit.

i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.

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.

Show More Criteria

17 exclusion criteria prevent from participating

vi) History of certain cardiovascular conditions within 6 months prior to screening.

i) Participants who have other forms of myopathies other than IIM.

Other protocol-defined inclusion/exclusion criteria apply.

x) Active, clinically significant, central nervous system (CNS) disorders.

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

All participants

Secondary Objectives

All participants

Systemic lupus erythematosus (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

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

Hopital Claude Huriez - CHU de LilleLille, FranceSee the location

Recruiting

Universitaetsklinikum Schleswig-Holstein Campus KielKiel, Germany

Recruiting

Universitätsklinikum Carl Gustav Carus an der TU DresdenDresden, Germany

Recruiting

Sheba Medical CenterRamat Gan, Israel

Recruiting

29 Study Centers

BMS-986515 CAR T Cells for Severe Refractory Autoimmune Diseases

BMS-986515

+ Fludarabine

+ Cyclophosphamide

Refractory Autoimmune Diseases

Treatment Study

Summary

Protocol

Single-Arm Study (No Allocation)

Single-Group Assignment

Non placebo-controlled Study

Open-Label Study

Eligibility

Conditions

Criteria

Study Plan

Treatment Groups

Study Objectives

Number of participants with treatment-emergent adverse events (TEAEs)

Number of participants with serious AEs (SAEs)

Number of participants with AEs of special interest (AESIs)

Number of participants with laboratory abnormalities

Number of participants with Dose-Limiting Toxicities (DLTs)

Number of participants with DLTs that occur during the DLT evaluation period

Maximum observed concentration (Cmax)

Area under the concentration-time curve (AUC)

Time of maximum observed concentration (Tmax)

Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24

Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24

Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24

Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24

Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24

Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24

Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline

Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline

Number of participants who achieve an minimal clinically important differences in SSc (MCID) from baseline of the modified Rodnan Skin Score (mRSS) at Week 24

Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24

Number of participants with low disease activity at Week 24 from baseline

Study Centers

This study has 29 locations