ABA-101 in Participants With Progressive Multiple Sclerosis

NCT06566261 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 101-PMS-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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

Keywords

Progressive Multiple Sclerosis; Cell Therapy; Multiple Sclerosis; Treg; Regulatory T Cell

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (safety and tolerability)

  Incidence of AEs through Day 29

  Day of Treatment to End of DLT Evaluation Period (28 Days)

Study Arms (2)

ABA-101 Dose 1

EXPERIMENTAL

Low Dose ABA-101

Biological: ABA-101

ABA-101 Dose 2

EXPERIMENTAL

High Dose ABA-101

Biological: ABA-101

Interventions

ABA-101 BIOLOGICAL

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

ABA-101 Dose 1; ABA-101 Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abata Therapeutics: lead

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Cleveland Clinic Mellen Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Samantha Singer, President and CEO, Abata Therapeutics, MS MBA

  Abata Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Escalating Dose Cohorts

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: September 11, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)