CC-97540 for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

+68 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Must be taking: High-efficacy DMTs, Immunosuppressants

Disqualifiers: Myositis, Stroke, CIDP, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants with relapsing forms of MS must have been on a high-efficacy disease-modifying therapy for at least 6 months, suggesting that some medications may need to be continued.

What makes the drug CC-97540 unique for treating multiple sclerosis?

CC-97540 is unique because it targets CD19, a marker found on certain B-cells, which are more prevalent in the cerebrospinal fluid of African American patients with multiple sclerosis. This focus on CD19 distinguishes it from other treatments like rituximab, which targets CD20, another B-cell marker. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have MS with recent worsening despite treatment.

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

Exclusion Criteria

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

I cannot walk 25 feet in less than 150 seconds.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-97540 to evaluate safety, tolerability, efficacy, and drug levels

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

78 weeks

Treatment Details

Interventions

• CC-97540 (Other)
• Cyclophosphamide (Alkylating agents)
• Fludarabine (Anti-metabolites)

Trial Overview 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.

Participant Groups

Group I: Administration of CC-97540 (RMS arm) Experimental Treatment 3 Interventions

Group II: Administration of CC-97540 (PMS arm) Experimental Treatment 3 Interventions

Group III: Administration of CC-97540 (MG arm) Experimental Treatment 3 Interventions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Local Institution - 0032 New Haven, CT

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, CA

Neurological Institute of New York New York, NY

Swedish Medical Center Seattle, WA

More Trial Locations

Who Is Running the Clinical Trial?

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

Celgene Corporation Industry Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

African American patients with Multiple Sclerosis (MS) have higher proportions of CD19+ and CD20+ B-cell lineage cells in their cerebrospinal fluid than White MS patients. [2023] To compare proportions of B-cell lineage CD19+ and CD20+ cells in CSF of African-American (AA) and White (W) patients with MS.

2. United States pubmed.ncbi.nlm.nih.gov

Intrathecal treatment trial of rituximab in progressive MS: An open-label phase 1b study. [2019] To perform a phase 1b assessment of the safety and feasibility of intrathecally delivered rituximab as a treatment for progressive multiple sclerosis (PMS) and to evaluate the effect of treatment on disability and CSF biomarkers during a 1-year follow-up period.

3. England pubmed.ncbi.nlm.nih.gov

Oral laquinimod in patients with relapsing-remitting multiple sclerosis: 36-week double-blind active extension of the multi-centre, randomized, double-blind, parallel-group placebo-controlled study. [2014] Laquinimod, an oral novel immunomodulator, was shown to reduce MRI-measured disease activity in relapsing-remitting MS (RRMS) patients.

4. Hungary pubmed.ncbi.nlm.nih.gov

[ALEMTUZUMAB: BENEFITS AND CHALLENGES OF A NEW THERAPY IN MULTIPLE SCLEROSIS]. [2019] The widening spectrum of MS treatment is partially due to increasing knowledge about the pathogenesis of MS. The humanized monoclonal antibody against CD52, alemtuzumab has been approved in Europe for the treatment of MS, which results in long-term depletion of B and T cells due to complement- and antibody-mediated cytotoxicity. Based on phase 2 and 3 clinical trials, alemtuzumob decreases the risk of sustained neurological deficit and progression compared to high-dose subcutaneous interferon-β1a in patients with active relapsing-remitting MS, either treatment-naïve or with breakthrough disease. We review advantages and benefits of the treatment, discuss safety concerns, and present a case to describe practical issues.

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of rituximab in relapsing and progressive multiple sclerosis: a hospital-based study. [2022] Rituximab is considered as a potential therapeutic option in relapsing-remitting (RRMS) and progressive forms (PMS) of multiple sclerosis (MS).