What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) that are immunomodulatory or immunosuppressive include interferon beta, glatiramer acetate, dimethyl fumarate, fingolimod, and alemtuzumab. Interferon beta can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Glatiramer acetate may lead to injection site reactions and, rarely, hepatotoxicity. Dimethyl fumarate is associated with gastrointestinal issues, flushing, and lymphopenia. Fingolimod can cause headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Alemtuzumab may result in infusion reactions, infections, and autoimmune disorders such as immune thrombocytopenia. These side effects should be discussed with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

Several immunomodulatory and immunosuppressive agents have been approved by the FDA for the treatment of Multiple Sclerosis (MS). Glatiramer acetate, an immunomodulator, is indicated for relapsing forms of MS and works by inducing specific T helper 2 type suppressor cells. Natalizumab, a monoclonal antibody, is used for relapsing MS but carries a risk of progressive multifocal leukoencephalopathy (PML). Alemtuzumab, another monoclonal antibody, is reserved for highly active relapsing MS due to its safety profile, including risks of serious infections and autoimmune disorders. These treatments aim to modulate or suppress the immune system to reduce the frequency and severity of MS relapses.

What other types of research exist?

Promising novel alternatives to CC-97540 for Multiple Sclerosis treatment include Fingolimod, which is an immune modulator with established efficacy and safety profiles, and Linomide, a synthetic immunomodulator that has shown potential in inhibiting disease progression in secondary progressive MS. Additionally, Alemtuzumab, indicated for highly active relapsing forms of MS, has demonstrated effectiveness in reducing relapse rates but comes with a risk of serious infections and autoimmune disorders.

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CC-97540 for Multiple Sclerosis

Q: What is the mechanism of action of this treatment?

Common treatments for Multiple Sclerosis (MS) often involve immunomodulatory and immunosuppressive agents. Interferon beta works by reducing inflammation and modulating the immune response, which helps decrease the frequency of relapses. Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the central nervous system and causing damage. Alemtuzumab targets and depletes immune cells that are involved in the autoimmune attack on myelin. These mechanisms are crucial for MS patients as they help manage the disease by reducing the immune system's attack on the nervous system, thereby slowing disease progression and reducing the frequency and severity of relapses.

Phase 1

Recruiting

Research Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progressive forms of MS - Cohort 2: Participants must have an EDSS ≥ 3.0 and ≤ 6.0. Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).

Be between 18 and 65 years old

Must not have

Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.

Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 104

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CC-97540 to see if it is safe and effective for people with relapsing or progressive multiple sclerosis. The goal is to find out if it can help manage symptoms or slow down the disease.

Who is the study for?

This trial is for individuals with Relapsing or Progressive Forms of Multiple Sclerosis. Specific eligibility details are not provided, but typically participants must meet certain health criteria and may be excluded based on factors that could impact their safety or the results of the study.

What is being tested?

The study is testing CC-97540, along with Fludarabine and Cyclophosphamide, to assess their safety, tolerability, effectiveness, and levels in the body among those with different forms of Multiple Sclerosis.

What are the potential side effects?

While specific side effects are not listed here, drugs like CC-97540 can cause immune system changes. Fludarabine and Cyclophosphamide often lead to nausea, weakness, infection risk increase, and potential liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have progressive MS with limited mobility and my condition is treatment-resistant or inactive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have MS lesions or symptoms that increase my risk of brain side effects.

Select...

I cannot walk 25 feet in less than 150 seconds.

Select...

I can complete a hand dexterity test in less than 4 minutes for each hand.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in magnetic resonance imaging (MRI) metrics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Administration of CC-97540 (RMS arm)Experimental Treatment3 Interventions

Group II: Administration of CC-97540 (PMS arm)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

CC-97540

2020

Completed Phase 1

~30

Fludarabine

2012

Completed Phase 4

~1860

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) often involve immunomodulatory and immunosuppressive agents. Interferon beta works by reducing inflammation and modulating the immune response, which helps decrease the frequency of relapses. Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the central nervous system and causing damage. Alemtuzumab targets and depletes immune cells that are involved in the autoimmune attack on myelin. These mechanisms are crucial for MS patients as they help manage the disease by reducing the immune system's attack on the nervous system, thereby slowing disease progression and reducing the frequency and severity of relapses.