ABA-101 in Participants With Progressive Multiple Sclerosis

June 30, 2025 updated by: Abata Therapeutics

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers, Robert Wood Johnson Medical School
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Mellen Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.

Exclusion 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABA-101 Dose 1
Low Dose ABA-101
Biological: ABA-101
ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy
Experimental: ABA-101 Dose 2
High Dose ABA-101
Biological: ABA-101
ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (safety and tolerability)
Time Frame: Day of Treatment to End of DLT Evaluation Period (28 Days)
Incidence of AEs through Day 29
Day of Treatment to End of DLT Evaluation Period (28 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abata Therapeutics

Investigators

  • Study Director: Samantha Singer, President and CEO, Abata Therapeutics, MS MBA, Abata Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-PMS-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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