RecruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

This research study is investigating a new treatment, BMS-986353 (also known as Zola-cel), for people living with a serious condition called Systemic Sclerosis. This condition causes the body's immune system to attack its own tissues, leading to symptoms in the skin, lungs, and other organs. The study aims to find out if BMS-986353 works better and is safer than the usual treatments doctors currently offer. It's a 'Phase 3' study, meaning it's one of the final steps before a new treatment might become widely available. Participants will either receive the new treatment or standard care, and doctors will carefully monitor their health and progress.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

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

Enrolment target

Start

29 May 2026

Estimated completion

11 Nov 2030

Systemic Sclerosis

What is this study about?

This study is for people who have a condition called Systemic Sclerosis, which is sometimes just called scleroderma. This is a long-term condition where your immune system mistakenly attacks your own body. This can cause changes to your skin, blood vessels, and internal organs like your lungs, heart, and digestive system. For some people, the condition can be very active and difficult to manage with current treatments.

The main goal of this study is to test a new treatment called BMS-986353, or Zola-cel. This treatment involves using special immune cells (CAR T cells) from your own body, which are then changed in a lab to specifically target and fight certain cells involved in Systemic Sclerosis. The doctors want to see if this new treatment works better than the standard treatments usually given for this condition, and importantly, if it is safe for people to use.

This is a comparison study, meaning some participants will receive the new treatment while others will receive standard care. This helps researchers understand the true effects of the new treatment. By taking part, you could be helping to find better ways to treat Systemic Sclerosis in the future.

Key takeaways

This study is testing a new treatment (BMS-986353) for Systemic Sclerosis.
It aims to see if the new treatment is more effective and safer than standard care.
Participants must have active Systemic Sclerosis, including lung involvement, and have tried other treatments.
You will receive either the new treatment or standard care under close medical supervision.

Who may be eligible?

To join this study, people must have a confirmed diagnosis of Systemic Sclerosis using specific medical guidelines. They also need to show signs of the disease affecting their lungs, along with other active symptoms like arthritis (joint pain), myositis (muscle inflammation), heart problems, worsening skin, or high inflammation levels.

Very importantly, participants must have already tried at least one standard treatment for their Systemic Sclerosis for at least six months, and it either hasn't worked well enough or they couldn't tolerate it. This study is generally for adults aged 16 and over.

There are also some reasons why someone might not be able to join. For example, if they need oxygen therapy, have severe lung problems not caused by Systemic Sclerosis, have very poor lung function, or serious heart or digestive issues requiring special feeding. People who have recently smoked or are unwilling to stop during the study, or who have current severe circulation problems in their fingers or toes, would also not be able to take part.

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.

Do I have a confirmed diagnosis of Systemic Sclerosis?
Does my Systemic Sclerosis affect my lungs and show other active symptoms?
Have I tried other Systemic Sclerosis treatments for at least 6 months, and they weren't effective or I couldn't tolerate them?
Am I generally healthy enough, without major unmanaged lung, heart, or digestive problems?
Am I over 16 years old?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be assigned to either receive the new treatment (BMS-986353) or continue with standard care, which might include medicines like Tocilizumab, Rituximab, or Nintedanib. If you're in the group receiving the new treatment, you'll likely also receive other medications like Fludarabine and Cyclophosphamide as part of the preparation.

The study involves regular visits to the clinic for check-ups, assessments, and to monitor your health and how you're responding to the treatment. These assessments will involve various tests, possibly including blood tests and scans, to track your Systemic Sclerosis activity and any side effects. If you're in the standard care group and your condition worsens, you might then be offered the new treatment. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has both possible benefits and risks. You might benefit from receiving a new treatment that could help your Systemic Sclerosis better than current options, or you might receive very close medical care and monitoring. However, there's always a chance that the new treatment might not work for you, or it could cause side effects, some of which could be serious. The doctors will explain all known risks of the treatments used. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (55)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0035
Verified postcode
Scottsdale, United States· Not yet recruiting
University of Colorado Anschutz Medical Campus
Verified postcode
Aurora, United States· Recruiting
Local Institution - 0001
Verified postcode
Denver, United States· Not yet recruiting
Local Institution - 0069
Verified postcode
Miami, United States· Not yet recruiting
Emory University School of Medicine
Verified postcode
Atlanta, United States· Recruiting
Local Institution - 0139
Verified postcode
Chicago, United States· Not yet recruiting
Local Institution - 0084
Verified postcode
Worcester, United States· Not yet recruiting
Local Institution - 0034
Verified postcode
Ann Arbor, United States· Not yet recruiting
Local Institution - 0037
Verified postcode
Rochester, United States· Not yet recruiting
Local Institution - 0082
Verified postcode
Summit, United States· Not yet recruiting
Local Institution - 0122
Verified postcode
Cleveland, United States· Not yet recruiting
Local Institution - 0142
Verified postcode
Philadelphia, United States· Not yet recruiting

Common questions

What is Systemic Sclerosis?

It's a long-term condition where your immune system attacks your body, causing changes to skin, blood vessels, and internal organs like the lungs.

What is BMS-986353?

It's a new, experimental treatment being tested in this study. It uses specially altered immune cells (CAR T cells) from your own body.

Will I definitely get the new treatment?

Not necessarily. Participants are randomly assigned to either receive the new treatment or standard care, and if in the standard care group, you may be considered for the investigational treatment if your disease progresses.

How long will the study last?

The study team will tell you the exact length of time you'll be involved, including follow-up appointments.

Can I stop being part of the study?

Yes, you can choose to leave the study at any time, for any reason, without affecting your medical care.

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.