ABA-101 in Participants with Progressive Multiple Sclerosis

Description

This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis. It is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.

Conditions

Progressive Multiple Sclerosis

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Study Overview

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Study Details

Study overview

This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis. It is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.

A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants with Progressive Multiple Sclerosis

ABA-101 in Participants with Progressive Multiple Sclerosis

Condition
Progressive Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Rutgers, Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Is ≥18 years old at signing of consent.
  • * Has a diagnosis of MS per the 2017 revised McDonald criteria.
  • * Has documented evidence of progression of disability independent of MS relapse activity (clinical or radiographic).
  • * Expresses the HLA that matches the TCR restriction.
  • * Presence of a radiographic biomarker of CNS inflammation as identified by MRI.
  • * Meets Expanded Disability Status Scale (EDSS) criteria.
  • * Meets the nine-hole peg test (9HPT) criteria.
  • * Presents with clinical or radiographic evidence of relapse within 24 months prior to or at Screening.
  • * Is considered by the Investigator to be immunocompromised.
  • * Current treatment with disease-modifying therapies (DMTs).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abata Therapeutics,

Study Record Dates

2027-02