RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)

This research, called "Breakfree-2," is testing a new medication, CC-97540, for people living with specific types of Multiple Sclerosis (MS) or a muscle weakness condition called Myasthenia Gravis (MG). We'll also be looking at how well people tolerate the new drug, if it helps their symptoms, and how much of the drug stays in their body. The study aims to understand if CC-97540 could be a helpful new treatment option for these conditions. It's in the first stage of testing, which means we're evaluating its safety and how the body handles it, as well as looking for early signs of how effective it might be.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

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

Enrolment target

120

Start

28 Mar 2024

Estimated completion

15 Jul 2027

Multiple Sclerosis Myasthenia Gravis

What is this study about?

This study is called "Breakfree-2" and it's looking into a new medication known as CC-97540. It's designed for people who have certain types of Multiple Sclerosis (MS) or a muscle weakness condition called Myasthenia Gravis (MG). The main goals are to find out if this new drug is safe to use, how well people can tolerate it (meaning, how easily they can live with any side effects), and if it has any positive effects on their condition. We'll also be checking how the drug moves through and stays in the body.

MS is a condition that affects your brain and spinal cord, which can lead to problems with movement, balance, and vision. MG is an autoimmune condition that causes muscles to become weak and tired easily. For both conditions, we are focusing on people whose illness is ongoing or hasn't responded well to other treatments. This study is an important step in potentially finding new ways to help manage these conditions.

We understand that taking part in a study like this is a big decision, and it’s important to know that your well-being is our top priority. We're carefully examining this new treatment to see if it could eventually offer a new option for patients. This is a "Phase 1" study, which means it's one of the first times this new drug is being tested in a small group of people to make sure it's safe and to understand how it works.

Key takeaways

This study tests a new drug, CC-97540, for specific MS and MG types.
It's a Phase 1 study, focusing on safety and how the body handles the drug.
Participation includes regular clinic visits and close monitoring.
You must be 18-60 years old and meet specific health criteria.
Potential benefits include access to new treatment, but side effects are possible.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you would generally need to be between 18 and 60 years old. The study is open to people with specific types of Multiple Sclerosis (MS) or Myasthenia Gravis (MG).

If you have Relapsing Multiple Sclerosis (RMS), your disability must be at a certain level, and your MS must have been active or getting worse in the past year, even while you were on other treatments. For those with Progressive Multiple Sclerosis (PMS), your disability also needs to be at a certain level, and your MS diagnosis should be either primary progressive (PPMS) that hasn't responded to treatment, or inactive secondary progressive (iSPMS).

If you have Myasthenia Gravis (MG), your condition needs to have been classified as moderate to severe, and you must have specific antibodies in your blood. Your MG also needs to be considered 'refractory', which means it hasn't improved much despite trying at least two different treatments, including steroids or other immune-suppressing drugs. There are also some physical tests you'd need to be able to complete, and you shouldn't have other health problems that could affect your muscle strength or make it harder to understand your MS or MG.

Quick self-check

Are you between 18 and 60 years old?
Do you have a diagnosis of certain types of Multiple Sclerosis (MS) or Myasthenia Gravis (MG)?
Has your MS or MG not responded well to other treatments?
Are you able to perform a few simple physical tests, like certain walking or hand movement tasks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments. During these visits, the study team would closely monitor your health and how you're feeling. You would receive the study medication, CC-97540, and possibly other approved medications like Fludarabine or Cyclophosphamide, depending on the study plan. You'll likely undergo various tests, such as blood tests, physical examinations, and possibly some tests to measure your MS or MG symptoms and how your body is reacting to the treatment. The total duration of your participation in the study, including follow-up, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new drug, CC-97540, proves to be effective in managing your Multiple Sclerosis or Myasthenia Gravis, especially if other treatments haven't worked well for you. However, as with any new treatment, there are potential risks, and you might experience side effects. The study team will explain all known side effects and monitor you closely for any new ones. Remember, joining a clinical study is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

University of Alabama at Birmingham
Birmingham, United States· Recruiting
University of California, Irvine
Irvine, United States· Recruiting
University of Colorado Anschutz Medical Campus
Aurora, United States· Recruiting
Colorado Blood Cancer Institute
Denver, United States· Recruiting
Yale-New Haven Hospital
New Haven, United States· Recruiting
University of Kansas Medical Center
Kansas City, United States· Recruiting
Local Institution - 0039
New Orleans, United States· Withdrawn
Local Institution - 0005
Boston, United States· Completed
Washington University School of Medicine
St Louis, United States· Recruiting
Hackensack University Medical Center
Hackensack, United States· Recruiting
Icahn School of Medicine at Mount Sinai
New York, United States· Recruiting
Neurological Institute of New York
New York, United States· Recruiting

+23 more sites — see the official record for the full list.

Common questions

What is CC-97540?

CC-97540 is a new drug being tested in this study to see if it can help people with certain types of Multiple Sclerosis or Myasthenia Gravis.

What are MS and MG?

MS (Multiple Sclerosis) affects the brain and spinal cord, causing problems with movement and balance. MG (Myasthenia Gravis) causes muscle weakness and tiredness due to an immune system issue.

Why is this study being done?

This study aims to find out if CC-97540 is safe, tolerable, and effective for people with specific forms of MS or MG, especially if current treatments aren't fully working.

What does 'Phase 1' mean?

Phase 1 means this is one of the first times the new drug is being tested in a small group of people to check its safety and how the body handles it.

Can I stop participating in the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it 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.