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CAR T-cell Therapy

ATA188 for Multiple Sclerosis (EMBOLD Trial)

Q: Is it possible for me to join this experiment?

This clinical trial is seeking 134 individuals, aged 18-60, suffering from primary progressive <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> (MS) who meet the additional criteria: For Part 1: Ages of 18 to &#x3C; 66 Years Old and EDSS Scores between 3.0 - 7.0; For Part 2: Ages of 18 to &#x3C; 61 years old with a current diagnosis according to 2017 Revised McDonald Criteria for MS, EDSS scores between 3.0 - 6.5 as well as positive EBV serology; Lastly, for Part 1 it is necessary that the patient has a history of progressive forms of MS according to 2010 Revised McDonald Criteria for

Q: Are there any remaining openings for participation in this research?

Clinicaltrials.gov states that this medical experiment is no longer accepting candidates. It was first listed on October 19th 2017 and the details were most recently modified on November 2nd 2022. Nevertheless, 549 other trials are currently open for enrollment across multiple sites.

Q: Are octogenarians able to partake in the experiment?

For this clinical trial, the age requirement to be enrolled is between 18 and 60 years old.

Q: What is the scope of facilities administering this experimental protocol?

This trial is recruiting patients from 33 locations, including The University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Health Science Center at Houston in Houston, Kaiser Permanente MS Clinic Los Angeles in Los Angeles and Vanderbilt Comprehensive <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">Multiple sclerosis</a> Center in Nashville.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 9 months after the first dose of study drug

Awards & highlights

EMBOLD Trial Summary

This trial is testing a new medication to treat multiple sclerosis. The safety and effectiveness of the medication will be determined.

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.Check my eligibility

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.See study design

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.

EMBOLD Trial 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.

EMBOLD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 months after the first dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 months after the first dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 months after the first dose of study drug for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: Incidence of adverse events

Part 1: Incidence of clinically significant changes in laboratory tests, electrocardiograms (ECGs), and vital signs

Part 1: Recommended Part 2 dose of ATA188 monotherapy

+1 more

Secondary outcome measures

Part 1: Change from baseline in EDSS score

Part 2: Change from baseline in immunoglobulin G (IgG) index

Part 2: Percentage of participants with SDI at 15 months

+2 more

Other outcome measures

Change from baseline in IgG production

Change from baseline in cervical spinal cord volume on MRI scans

Change from baseline in number of Gd-enhancing and new or enlarging T2 lesions on brain MRI scans

+1 more

EMBOLD 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Atara BiotherapeuticsLead Sponsor

12 Previous Clinical Trials

571 Total Patients Enrolled

Kiren Kresa-Reahl, MDStudy DirectorAtara Biotherapeutics

1 Previous Clinical Trials

430 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

430 Patients Enrolled for Multiple Sclerosis

Media Library

ATA188 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03283826 — Phase 1 & 2

Multiple Sclerosis Research Study Groups: ATA188, Placebo

Multiple Sclerosis Clinical Trial 2023: ATA188 Highlights & Side Effects. Trial Name: NCT03283826 — Phase 1 & 2

ATA188 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03283826 — Phase 1 & 2

Frequently Asked Questions

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

Is it possible for me to join this experiment?

"This clinical trial is seeking 134 individuals, aged 18-60, suffering from primary progressive multiple sclerosis (MS) who meet the additional criteria: For Part 1: Ages of 18 to < 66 Years Old and EDSS Scores between 3.0 - 7.0; For Part 2: Ages of 18 to < 61 years old with a current diagnosis according to 2017 Revised McDonald Criteria for MS, EDSS scores between 3.0 - 6.5 as well as positive EBV serology; Lastly, for Part 1 it is necessary that the patient has a history of progressive forms of MS according to 2010 Revised McDonald Criteria for"

Answered by AI

Are there any remaining openings for participation in this research?

"Clinicaltrials.gov states that this medical experiment is no longer accepting candidates. It was first listed on October 19th 2017 and the details were most recently modified on November 2nd 2022. Nevertheless, 549 other trials are currently open for enrollment across multiple sites."

Answered by AI

Are octogenarians able to partake in the experiment?

"For this clinical trial, the age requirement to be enrolled is between 18 and 60 years old."

Answered by AI

What is the scope of facilities administering this experimental protocol?

"This trial is recruiting patients from 33 locations, including The University of Texas Health Science Center at Houston in Houston, Kaiser Permanente MS Clinic Los Angeles in Los Angeles and Vanderbilt Comprehensive Multiple sclerosis Center in Nashville."

Answered by AI