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OpenTrials
Active, Not Recruiting

NCT Number: NCT06566261

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ABA-101

Biological

ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abata Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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