NCT06566261Active, not recruitingPhase 1
ABA-101 in Participants With Progressive Multiple Sclerosis
A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants With Progressive Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 20 Aug 2024
- Start date
- 11 Sept 2024
- Primary completion date
- Feb 2026
- Lead sponsor
- Abata Therapeutics
- Diseases
- Multiple sclerosis
- NCT number
- NCT06566261
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 11 Sept 2024 to the primary completion date, Feb 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presents with clinical or radiographic evidence of relapse within 24 months prior to or at Screening.
- Current treatment with disease-modifying therapies (DMTs).
Other
- Is considered by the Investigator to be immunocompromised.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Cleveland Clinic Mellen Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Rutgers, Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.