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 Sex
- 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
More Details
- NCT ID
- NCT06566261
- Status
- Active, not recruiting
- Sponsor
- Abata Therapeutics