ATA188 for Multiple Sclerosis

(EMBOLD Trial)

Recruiting at35 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Atara Biotherapeutics

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kiren Kresa-Reahl, MD

Principal Investigator

Atara Biotherapeutics

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old.

I have a progressive form of multiple sclerosis.

I have been diagnosed with a progressive form of MS.

Exclusion Criteria

Inability or unwillingness to comply with study procedures

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

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

Treatment Details

Interventions

• ATA188 (CAR T-cell Therapy)

Trial Overview 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.

Participant Groups

Group I: ATA188 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 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).

Who Is Running the Clinical Trial?

Atara Biotherapeutics

Lead Sponsor

Trials

14

Recruited

740+