RecruitingPHASE1INTERVENTIONAL

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

This study is looking into a new treatment called BMS-986515, which uses special immune cells (CAR T cells) from healthy donors. It's for people with serious autoimmune diseases like lupus, inflammatory muscle disease, and rheumatoid arthritis, especially if their current medication isn't working well. The main goals are to check if the treatment is safe, to find the best amount of the treatment to give, and to see if it helps improve these conditions. Researchers are also using other standard medications like fludarabine, cyclophosphamide, and tocilizumab as part of the study. This is an early-stage study, meaning it's one of the first times this treatment is being tested in people.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

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

Enrolment target

125

Start

04 Sep 2025

Estimated completion

16 Aug 2030

Refractory Autoimmune Diseases

What is this study about?

This research study is about a new way to treat severe autoimmune diseases. In autoimmune diseases, your body's immune system, which normally fights off infections, mistakenly attacks your own healthy tissues. This can cause a lot of different problems and symptoms.

The new treatment being tested is called BMS-986515. It's a special kind of cell therapy, sometimes called CAR T-cell therapy. What makes it unique is that these special cells come from healthy donors, not the patient themselves. The idea is to use these specially-prepared cells to calm down the overactive immune system that is causing the autoimmune disease.

The main reasons for this study are to make sure this new treatment is safe for people to use, to figure out the right amount (dose) that works best, and to see if it can help improve conditions for people who haven't found enough relief from other treatments. This is an important step in developing new options for a range of difficult-to-treat autoimmune conditions.

Key takeaways

This is a study of a new cell therapy (BMS-986515) for severe autoimmune diseases.
It's for people whose current treatments aren't working well enough.
The main goals are to check safety, find the best dose, and see if it helps.
It's an early-stage study (Phase 1), meaning it's one of the first times it's used in people.
You will be closely monitored if you participate.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. The study is looking for people with severe forms of certain autoimmune diseases. These include Systemic Lupus Erythematosus (SLE), Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), and Rheumatoid Arthritis (RA).

Specifically, for lupus, you need a confirmed diagnosis, certain antibody tests positive, active disease, and current treatments not working well enough. For inflammatory myopathy, a confirmed diagnosis, severe and active disease, and previous treatments not being effective are important. For systemic sclerosis, you need a confirmed diagnosis, ongoing active disease (especially affecting skin or lungs), and previous treatments not helping enough. For rheumatoid arthritis, you need a confirmed diagnosis of difficult-to-treat and active RA, with your current treatments not providing enough relief.

There are also some reasons why you wouldn't be able to join. These include having another major autoimmune disease, pregnancy or breastfeeding, certain infections like active hepatitis B or C or HIV, a history of cancer, uncontrolled infections, certain heart problems in the last six months, or having had any CAR T-cell therapy before. Significant lung issues or an unplanned pregnancy in the future would also prevent you from participating.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe lupus, inflammatory muscle disease, systemic sclerosis, or rheumatoid arthritis?
Have your current treatments not worked well enough for your condition?
Are you NOT pregnant or breastfeeding?
Do you NOT have an active infection like hepatitis, HIV, or an uncontrolled infection?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic to receive the study treatment and to have various tests and check-ups. You would receive the study drug BMS-986515, as well as other standard medications such as fludarabine, cyclophosphamide, and tocilizumab, which are used to prepare your body for the cell therapy and help manage potential side effects. These medications would be given according to the study plan.

Doctors and nurses would closely monitor your health throughout the study, which would include regular blood tests, physical exams, and other assessments to check how you are responding to the treatment and to look for any side effects. The total duration of your participation in the study, including follow-up appointments, would be explained to you in detail by the study team. You would be informed about the schedule of visits and what each visit would involve.

Potential risks and benefits

Like all medical studies, there could be potential benefits and potential risks. The potential benefit is that this new treatment, BMS-986515, might help improve your severe autoimmune disease, especially if current treatments haven't worked for you. However, as this is an early-stage study, we don't yet know how effective it will be. Potential risks can include side effects from the study medication or the preparations, which the study team will discuss in detail and monitor very closely. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (28)

Brigham And Womens Hospital
Verified postcode
Boston, United States· Recruiting
Duke University
Verified postcode
Durham, United States· Recruiting
Local Institution - 0007
Verified postcode
Camperdown, Australia· Not yet recruiting
Local Institution - 0008
Verified postcode
Brisbane, Australia· Withdrawn
Local Institution - 0013
Verified postcode
Clayton, Australia· Not yet recruiting
Local Institution - 0040
Verified postcode
Salvador, Brazil· Not yet recruiting
Local Institution - 0039
Verified postcode
Porto Alegre, Brazil· Not yet recruiting
Local Institution - 0038
Verified postcode
São Paulo, Brazil· Not yet recruiting
Local Institution - 0004
Verified postcode
Prague, Czechia· Not yet recruiting
Revmatologicky ustav
Verified postcode
Prague, Czechia· Recruiting
CHU Strasbourg-Hautepierre
Verified postcode
Strasbourg, France· Recruiting
Hopital Claude Huriez - CHU de Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is an autoimmune disease?

An autoimmune disease is when your body's immune system, which normally fights off germs, mistakenly attacks your own healthy tissues and organs.

What are CAR T cells?

CAR T cells are special immune cells that have been changed in a lab to better recognise and fight against specific targets, in this case, a protein called CD19, to help treat disease.

What does 'refractory' mean?

'Refractory' means that your disease hasn't responded well to usual treatments, or that you couldn't tolerate those treatments.

Is this treatment a cure?

This is an early-stage study to see if the treatment is safe and if it helps. It's not yet known if it will be a cure for autoimmune diseases.

Will I get paid to be in the study?

Participation in a clinical trial may involve travel and other expenses. Compensation for these expenses, if any, will be discussed by the study team during your initial visit.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.