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CC-97540 for Multiple Sclerosis
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
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 belowSelect...
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
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
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
CC-97540
2020
Completed Phase 1
~30
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2310
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.
Find a Location
Who is running the clinical trial?
Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
58,548 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
80 Patients Enrolled for Multiple Sclerosis
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor
15 Previous Clinical Trials
2,069 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,564 Previous Clinical Trials
3,383,927 Total Patients Enrolled
12 Trials studying Multiple Sclerosis
17,068 Patients Enrolled for Multiple Sclerosis
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