What is the mechanism of action of this treatment?

Multiple Sclerosis (MS) treatments primarily aim to modulate the immune system to reduce inflammation and prevent further damage to the nervous system. Common treatments include interferon beta, which reduces the frequency of relapses by modulating immune response, and glatiramer acetate, which mimics myelin proteins to divert immune attacks away from nerve fibers. Targeted immunotherapies, such as ATA188, focus on specific immune cells implicated in MS, aiming to reduce disease activity with potentially fewer side effects. These therapies are crucial for MS patients as they offer the potential for more effective management of the disease with a tailored approach, potentially improving quality of life and slowing disease progression.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta-1a, glatiramer acetate, and oral therapies like dimethyl fumarate. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and liver enzyme abnormalities. Glatiramer acetate may lead to injection site reactions, lipoatrophy, and transient systemic reactions such as chest pain and palpitations. Dimethyl fumarate is associated with flushing, gastrointestinal issues, and lymphopenia. Targeted immunotherapies like ATA188, while still under study, aim to minimize these side effects by specifically targeting immune cells involved in MS pathology.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS) that involve immunomodulation and targeted immunotherapy. Notable examples include glatiramer acetate, which modulates the immune response by mimicking myelin basic protein, and alemtuzumab, which targets CD52 on immune cells to reduce their activity. Additionally, natalizumab, an antibody that inhibits immune cell migration into the central nervous system, and dimethyl fumarate, which has immunomodulatory and anti-inflammatory effects, have been approved. These treatments aim to reduce relapse rates and slow disease progression in MS patients.

What other types of research exist?

Promising novel alternatives to ATA188 for Multiple Sclerosis patients include: 1) Alemtuzumab, a lymphocyte-depleting anti-CD52 monoclonal antibody, which has shown efficacy in phase 2 and 3 trials. 2) Ocrelizumab, an anti-CD20 monoclonal antibody, which has demonstrated positive results in phase 3 clinical trials. 3) Ofatumumab, another anti-CD20 monoclonal antibody, currently in phase 2 trials. These therapies have shown potential in reducing disease progression and improving clinical outcomes in MS patients.

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CAR T-cell Therapy

ATA188 for Multiple Sclerosis (EMBOLD Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Atara Biotherapeutics

Eligibility Criteria Checklist

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

Must have

For Part 1: 18 to < 66 years of age

For Part 1: History of progressive forms of MS (PPMS or SPMS), as defined by the 2010 Revised McDonald criteria for the diagnosis of MS

Must not have

Prior therapy with corticosteroids (within 2 weeks before Cycle 1 Day 1)

For Part 2: Prior therapy (6 half-lives or 30 days whichever is longer) with IV immunoglobin, plasmapheresis, Bruton's tyrosine kinase inhibitors, all sphingosine 1-phosphate receptor modulators (eg, fingolimod), glatiramer acetate, interferon β, nuclear factor (erythroid-derived 2)-like 2 (Nrf2) activators (eg, dimethyl fumarate), methotrexate, azathioprine, cyclosporine, natalizumab, teriflunomide, mitoxantrone, cyclophosphamide, any other immunosuppressant or cytotoxic therapy (other than steroids), antithymocyte globulin or similar anti-T-cell antibody therapy, or any other investigational product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests ATA188, a treatment given through a vein, in adults with progressive forms of multiple sclerosis. The treatment is customized to each patient's immune system to see if it can improve their condition.

Who is the study for?

This trial is for adults with progressive forms of multiple sclerosis (PPMS or SPMS) who have certain levels of disability (EDSS scores between 3.0 to 6.5 or up to 7.0 in Part 1). Participants must test positive for EBV and be willing to use contraception if applicable. Excluded are those with recent immunosuppressant treatments, serious medical conditions, pregnancy, breastfeeding women, and anyone unable to follow the study procedures.

What is being tested?

The trial is testing ATA188's safety and ability to improve clinical disability in MS patients compared with a placebo. It aims to find the best dose in Part 1 and then assess its effectiveness on disability at the one-year mark in Part 2 using EDSS score improvements as a measure.

What are the potential side effects?

While specific side effects aren't listed here, common risks may include reactions at injection sites, flu-like symptoms, potential liver issues indicated by blood tests, allergic reactions or worsening of MS symptoms temporarily after administration.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have a progressive form of multiple sclerosis.

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I have been diagnosed with a progressive form of MS.

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I am between 18 and 60 years old.

Exclusion Criteria

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

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I haven't taken corticosteroids in the last 2 weeks.

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I haven't taken specific immune or cancer treatments recently.

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I don't have any serious health issues that would make it unsafe for me to join the study.

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I have tested positive for HIV, HBV, or HCV.

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I have previously received treatments like cladribine or stem cell transplant.

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I am unwilling to use the specified birth control methods in the study.

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I have previously received alemtuzumab, a stem cell transplant, or EBV T-cell therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ATA188Experimental Treatment1 Intervention

Participants in Parts 1 and 2 will receive ATA188 intravenously as described in the Detailed Description.

Group II: PlaceboPlacebo Group1 Intervention

Participants in Part 2 will receive placebo matching to ATA188 intravenously as described in the Detailed Description (i.e., will receive placebo only in the first year, and thereafter will receive ATA188 for the remainder of the study).

0 / 11Eligibility 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

Multiple Sclerosis (MS) treatments primarily aim to modulate the immune system to reduce inflammation and prevent further damage to the nervous system. Common treatments include interferon beta, which reduces the frequency of relapses by modulating immune response, and glatiramer acetate, which mimics myelin proteins to divert immune attacks away from nerve fibers. Targeted immunotherapies, such as ATA188, focus on specific immune cells implicated in MS, aiming to reduce disease activity with potentially fewer side effects. These therapies are crucial for MS patients as they offer the potential for more effective management of the disease with a tailored approach, potentially improving quality of life and slowing disease progression.