ABA-101 in Participants With Progressive Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Progressive Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Escalating Dose Cohorts

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABA-101 Dose 1

Low Dose ABA-101

Group Type EXPERIMENTAL

ABA-101

Intervention Type BIOLOGICAL

ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy

ABA-101 Dose 2

High Dose ABA-101

Group Type EXPERIMENTAL

ABA-101

Intervention Type BIOLOGICAL

ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy

Interventions

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ABA-101

ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No