ABA-101 in Participants With Progressive Multiple Sclerosis

Abata Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Progressive Multiple Sclerosis

Treatments: Biological: ABA-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06566261

101-PMS-101

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

ABA-101 Dose 1

Experimental group

Description:

Low Dose ABA-101

Treatment:

Biological: ABA-101

ABA-101 Dose 2

Experimental group

Description:

High Dose ABA-101

Treatment:

Biological: ABA-101