ABA-101 in Participants With Progressive Multiple Sclerosis | NCT06566261

Studies
ABA-101 in Participants With Progressive Multiple Sclerosis

NCT06566261

Sponsor

Abata Therapeutics

Status

Active, not recruiting

Last Update Posted

Jul 3, 2025Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Progressive Multiple Sclerosis

Interventions

ABA-101

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2024Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Aug 20, 2024

First Submission Date that Met QC Criteria

Aug 20, 2024

First Posted Date

Aug 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2025

Last Update Posted Date

Jul 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABA-101 Dose 1	Experimental	Low Dose ABA-101	Biological: ABA-101
ABA-101 Dose 2	Experimental	High Dose ABA-101	Biological: ABA-101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABA-101	Biological	ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy	ABA-101 Dose 1 ABA-101 Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (safety and tolerability)	Incidence of AEs through Day 29	Day of Treatment to End of DLT Evaluation Period (28 Days)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samantha Singer, President and CEO, Abata Therapeutics, MS MBA	Abata Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21287	United States
Rutgers, Robert Wood Johnson Medical School

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020528	Multiple Sclerosis, Chronic Progressive
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided