Testing ABA-101 for treating progressive multiple sclerosis
A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants With Progressive Multiple Sclerosis
This study is testing a new cell therapy called ABA-101 to see if it can safely help people with progressive multiple sclerosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abata Therapeutics Industry-sponsored |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT06566261 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effects of ABA-101, a cell therapy, administered as a single dose to participants diagnosed with progressive multiple sclerosis. The study will begin with a low dose to assess safety before progressing to a higher dose if deemed appropriate. Participants must meet specific eligibility criteria, including evidence of disease progression and certain radiographic markers. This is the first time ABA-101 will be tested in humans, marking a significant step in exploring new treatments for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of progressive multiple sclerosis and evidence of disease progression.
Not a fit: Patients who have experienced a relapse within the last 24 months or are currently on disease-modifying therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with progressive multiple sclerosis.
How similar studies have performed: While this approach is novel in humans, similar studies in preclinical models have shown promise in targeting regulatory T cells for autoimmune conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Rutgers, Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Recruiting)
- Cleveland Clinic Mellen Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Leonard Dragone, MD PhD
- Email: abatatxclinicaltrials@abatatx.com
- Phone: 855-282-5770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.