ABA-101 in Participants With Progressive Multiple Sclerosis
Purpose
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.
Condition
- Progressive Multiple Sclerosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Sequential Escalating Dose Cohorts
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABA-101 Dose 1 |
Low Dose ABA-101 |
|
|
Experimental ABA-101 Dose 2 |
High Dose ABA-101 |
|
Recruiting Locations
Johns Hopkins University
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
Cleveland Clinic Mellen Center
Cleveland, Ohio 44195
Cleveland, Ohio 44195
More Details
- NCT ID
- NCT06566261
- Status
- Recruiting
- Sponsor
- Abata Therapeutics