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
What it found
No result yet.
What was tested
Treatment tested
- ABA-101
What it measured
Main measures
Incidence of adverse events (safety and tolerability)
Day of Treatment to End of DLT Evaluation Period (28 Days)
Safety
Who could take part
Progressive MS · 18 and over
Show the full 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).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Sept 2024
Main results due
Feb 2026
Finished
Feb 2027