ABA-101 in Participants With Progressive Multiple Sclerosis

Phase 1

Active, not recruiting

• Conditions: Progressive Multiple Sclerosis
• Interventions: Biological: ABA-101

• Registration Number: NCT06566261
• Lead Sponsor: Abata Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Study Start: 2024-09-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-02
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ABA-101 Dose 2	ABA-101	High Dose ABA-101
ABA-101 Dose 1	ABA-101	Low Dose ABA-101

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (safety and tolerability)	Day of Treatment to End of DLT Evaluation Period (28 Days)	Incidence of AEs through Day 29

Trial Locations

Locations (3)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Rutgers, Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

Cleveland Clinic Mellen Center; 🇺🇸 Cleveland, Ohio, United States