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Administration of CC-97540 (PMS arm) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 104

Awards & highlights

Study Summary

This trial aims to test the safety, effectiveness, and drug levels of CC-97540 in people with either Relapsing Forms or Progressive Forms of Multiple Sclerosis.

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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs)

Number of participants with adverse events of special interest (AESIs)

Number of participants with dose-limiting toxicities (DLTs)

+4 more

Secondary outcome measures

Annualized relapse rate

Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

Change from baseline in magnetic resonance imaging (MRI) metrics

+6 more

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

Fludarabine

2012

Completed Phase 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,138 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

80 Patients Enrolled for Multiple Sclerosis

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor

14 Previous Clinical Trials

1,629 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,508 Previous Clinical Trials

3,370,325 Total Patients Enrolled

10 Trials studying Multiple Sclerosis

17,640 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have an age limit for potential participants, specifically individuals who are 50 years old or older?

"In order to be considered for participation in this trial, individuals must meet the age requirement of being at least 18 years old and no older than 65 years."

Answered by AI

Which individuals are considered the most suitable candidates to participate in this research study?

"To be eligible for participation in this clinical trial, prospective patients must have a diagnosis of multiple sclerosis and fall within the age range of 18 to 65 years old. The study aims to enroll approximately 98 individuals."

Answered by AI

Are there any ongoing efforts to enlist participants for this research study at the moment?

"As per the information available on clinicaltrials.gov, this study is not currently seeking participants. The trial was initially posted on January 15th, 2024, and most recently updated on January 22nd, 2024. However, it's worth noting that there are presently 530 other ongoing clinical trials actively enrolling patients at this time."

Answered by AI

Has the Food and Drug Administration officially authorized the use of CC-97540 (RMS arm) as a treatment option?

"This trial is categorized as a Phase 1 study, suggesting that there is limited evidence available to support the safety and effectiveness of administering CC-97540 (RMS arm). As a result, our team at Power assigns it a safety rating of 1."

Answered by AI

At how many different venues is this experimental investigation currently being supervised?

"To minimize travel requirements for participants, it is advisable to select the trial site that is geographically closest. This study currently operates in 20 different locations, including Manchester, Philadelphia, València, and various other cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis

2024. "A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06220201.

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