CC-97540 for Multiple Sclerosis

Recruiting at 74 trial locations

Overseen By Aram Zabeti, Site 0038

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must be taking: High-efficacy DMTs, Immunosuppressants

Disqualifiers: Myositis, Stroke, CIDP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new treatment called CC-97540 to determine its safety and effectiveness for individuals with certain types of multiple sclerosis (MS) or myasthenia gravis (MG). It targets those with relapsing MS experiencing frequent flare-ups, progressive MS unresponsive to treatment, or MG that does not respond to at least two types of medication. Participants will assist researchers in understanding how this drug behaves in the body and its effects on these conditions. For those with these conditions whose treatments have been ineffective, this trial might be suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that CC-97540 is in the early stages of testing to determine its safety for people. Early results suggest it might help reset the immune system, potentially benefiting those with autoimmune diseases like multiple sclerosis or myasthenia gravis. However, detailed safety information remains limited due to its early phase. The primary goal of this phase is to assess the treatment's safety and tolerability. So far, no major safety issues have been reported. Nonetheless, further studies are necessary to fully understand its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple sclerosis, which often include immunomodulatory drugs like interferons and glatiramer acetate, CC-97540 offers a novel approach. This experimental drug is intriguing because it might target specific pathways involved in the progression of multiple sclerosis, potentially offering a more tailored therapeutic effect. Researchers are excited because this could mean more effective management of symptoms and possibly slowing disease progression, offering hope for improved outcomes compared to existing options.

What evidence suggests that this trial's treatments could be effective for Multiple Sclerosis and Myasthenia Gravis?

Research shows that CC-97540 is an experimental therapy using modified immune cells to target a protein called CD19, often found on immune cells. This treatment resembles an FDA-approved therapy, lisocabtagene maraleucel, used for certain blood cancers. Early studies suggest that CC-97540 might help treat autoimmune diseases by altering immune cell function. This trial tests CC-97540 for conditions like multiple sclerosis and myasthenia gravis, where the immune system mistakenly attacks the body. Initial results appear promising, but further research is needed to confirm its effectiveness and safety for these conditions. ^{1 2 3 4 5}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CC-97540
• Cyclophosphamide
• Fludarabine

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

19

Recruited

3,100+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Published Research Related to This Trial

Alemtuzumab, a humanized monoclonal antibody targeting CD52, has been approved for treating multiple sclerosis (MS) in Europe and is effective in long-term depletion of B and T cells, which helps reduce neurological deficits.

Clinical trials (phase 2 and 3) show that alemtuzumab significantly lowers the risk of sustained neurological decline compared to high-dose interferon-β1a in patients with active relapsing-remitting MS, whether they are treatment-naïve or experiencing breakthrough disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ALEMTUZUMAB: BENEFITS AND CHALLENGES OF A NEW THERAPY IN MULTIPLE SCLEROSIS]. Illés, Z., Sejbaek, T., Csépány, T.[2019]

In a study of 90 patients with relapsing-remitting and progressive multiple sclerosis, rituximab treatment led to an impressive 88.4% reduction in the annualized relapse rate and a significant decrease in disability status after one year.

Rituximab was found to be generally safe, with mild infusion-related symptoms being the most common side effect, although three thrombotic events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of rituximab in relapsing and progressive multiple sclerosis: a hospital-based study. Alcalá, C., Gascón, F., Pérez-Miralles, F., et al.[2022]

In a 36-week extension study involving 257 patients with relapsing-remitting MS, laquinimod demonstrated sustained efficacy by significantly reducing MRI-measured disease activity, particularly in patients who switched from placebo to treatment, with a 52% reduction in gadolinium-enhanced lesions.

The safety profile of laquinimod was confirmed, with the most notable side effect being reversible elevations in liver enzymes, indicating that it is well-tolerated by patients.

NCBI (Pubmed)

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. Comi, G., Abramsky, O., Arbizu, T., et al.[2014]

In a study comparing 20 African-American (AA) and 56 White (W) patients with multiple sclerosis (MS), AA patients showed significantly higher proportions of CD19+ (5.46% vs. 2.26%) and CD20+ (4.64% vs. 1.91%) B-cells in their cerebrospinal fluid (CSF).

The findings suggest that B-cells are overrepresented in the CSF of AA MS patients compared to W patients, which may have implications for understanding disease mechanisms and treatment responses in different racial groups.

NCBI (Pubmed)

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. Xue, H., Arbini, AA., Melton, HJ., et al.[2023]

Intrathecal delivery of rituximab in 23 patients with progressive multiple sclerosis was generally well tolerated, with only mild to moderate side effects like vertigo and nausea, although there was a risk of severe infections such as bacterial meningitis.

After one year of treatment, there was minimal evidence of clinical improvement or changes in cerebrospinal fluid biomarkers, indicating that while the treatment is feasible, its efficacy remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal treatment trial of rituximab in progressive MS: An open-label phase 1b study. Bergman, J., Burman, J., Gilthorpe, JD., et al.[2019]

Citations

1. news.bms.com news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Encouraging-Data-from-Phase-1-Breakfree-1-Study-of-CD19-NEX-T-CAR-T-Cell-Therapy-in-Three-Chronic-Autoimmune-Diseases-at-ACR-Convergence-2025/default.aspx

Corporate news details ... CD19-targeted NEX-T™ CAR T cell therapy BMS-986353 (CC-97540). The data, evaluating a total of 71 treated patients across the systemic sclerosis ...

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2088/529040/Tolerability-Efficacy-Pharmacokinetics-and

Tolerability, Efficacy, Pharmacokinetics, and ... BMS-986353 (CC-97540) is an investigational CAR T cell therapy expressing the CD19-targeting CAR used in FDA-approved lisocabtagene maraleucel (liso-cel).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05869955

NCT05869955 | A Study of CC-97540, CD-19-Targeted ... The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124048353

Tolerability, Efficacy, Pharmacokinetics, and ... BMS-986353 (CC-97540) is an investigational CAR T cell therapy expressing the CD19-targeting CAR used in FDA-approved lisocabtagene maraleucel (liso-cel). BMS- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06220201

NCT06220201 | A Study to Evaluate the Safety, Tolerability ... The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple ...