Progressive Multiple Sclerosis
Conditions
Keywords
Progressive Multiple Sclerosis, Cell Therapy, Multiple Sclerosis, Treg, Regulatory T Cell
Brief summary
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.
Interventions
BIOLOGICALABA-101
ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy
Sponsors
Abata Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential Escalating Dose Cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (safety and tolerability) | Day of Treatment to End of DLT Evaluation Period (28 Days) | Incidence of AEs through Day 29 |
Countries
United States
Outcome results
None listed