BMS-986515 for Autoimmune Diseases

Recruiting at 42 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Disqualifiers: Other autoimmune diseases, Pregnancy, Hepatitis, HIV, Malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986515 to determine its safety and effectiveness for individuals with severe autoimmune diseases that have not responded well to other treatments. Researchers focus on conditions such as lupus, inflammatory muscle diseases, systemic sclerosis (a connective tissue disease), and difficult-to-treat rheumatoid arthritis. Participants should have active disease and a history of inadequate response to standard treatments like steroids or immunosuppressive medicines. Those with one of these conditions who struggle with current treatments might find this trial suitable. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BMS-986515 is likely to be safe for humans?

Research shows that BMS-986515 is a new cell therapy derived from healthy donor cells. This treatment is undergoing safety testing in individuals with severe autoimmune diseases unresponsive to other treatments. As BMS-986515 is in the early testing stages, information about its safety in humans remains limited. Early trials primarily focus on ensuring the treatment's safety and determining the optimal dose.

Researchers closely monitor participants' responses to the treatment and any side effects. Since this trial is in an early phase, researchers continue to gather crucial safety information. Although detailed data may be scarce, participation in this trial contributes to understanding the safety of BMS-986515 and its potential future benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BMS-986515 is unique because it targets autoimmune diseases with a novel approach. Unlike traditional treatments that often suppress the immune system broadly, BMS-986515 works by specifically modulating certain immune pathways, potentially leading to fewer side effects. Researchers are excited about this treatment because it represents a more targeted method, which could offer better management of autoimmune conditions while minimizing the risks associated with current therapies.

What evidence suggests that BMS-986515 might be an effective treatment for autoimmune diseases?

Research has shown that BMS-986515, which participants in this trial will receive, could be a promising treatment for severe autoimmune diseases unresponsive to other treatments. This treatment uses CAR T cells, immune cells modified to find and attack unhealthy cells. Early studies suggest these CAR T cells can specifically target CD19, a protein often found on harmful cells in autoimmune diseases. Although human trial data is limited, using CAR T cells to target specific proteins like CD19 is a well-researched method in treating some cancers, indicating potential effectiveness for autoimmune diseases. By targeting CD19, BMS-986515 could help reduce symptoms and slow disease progression. ^{1 4 5 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for individuals with severe autoimmune diseases that haven't improved with other treatments. These include conditions like lupus, rheumatoid arthritis, and various skin and muscle disorders. Participants should be in stable condition to receive the therapy.

Inclusion Criteria

I have systemic lupus erythematosus.

I have been diagnosed with rheumatoid arthritis according to the 2010 criteria.

Steroids and other immune treatments didn't work well for me.

Exclusion Criteria

I have a muscle disease that is not inflammatory myopathy.

SLE population:

Participants who have SLE because of drugs or have other autoimmune diseases along with SLE

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986515, a healthy donor allogeneic CD19-targeted CAR T cell product

4 weeks

1 visit (in-person) for infusion

DLT Evaluation

Participants are monitored for dose-limiting toxicities post-infusion

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986515

Trial Overview The study tests BMS-986515 (a type of CAR T cell therapy), along with drugs Fludarabine and Cyclophosphamide to prepare the body, followed by Tocilizumab if needed for side effects. It aims to find a safe dose and see how well it works against tough autoimmune diseases.

How Is the Trial Designed?

Group I: BMS-986515 Administration Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

19

Recruited

3,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07115745

A Study of Healthy Donor CD19-targeted Allogeneic CAR T ... The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic ...

2. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

Corporate news details New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; ...

3. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT07115745

Trial ID IM060-0001 | NCT07115745 - BMS Clinical Trials The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic ...

4. finance.yahoo.com finance.yahoo.com/news/strong-trial-results-autoimmune-diseases-032216309.html

Strong Trial Results in Autoimmune Diseases Might ... In October 2025, Bristol-Myers Squibb reported positive Phase 3 and Phase 2 trial results for Sotyktu in psoriatic arthritis and systemic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142172/

efficacy on patient-reported outcomes in a phase ... Patients with SLE experienced greater improvements in pain, fatigue and health-related quality-of-life scores at week 48 with deucravacitinib versus placebo ...

6. bmsstudyconnect.com bmsstudyconnect.com/at/de/clinical-trials/NCT07115745.html

Studien-Nr. IM060-0001 | NCT07115745 - BMS Clinical Trials The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic ...

7. patlynk.com patlynk.com/trial/NCT07115745

BMS-986515 CAR T Cells for Severe Refractory ... 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 ...