Progressive Multiple SclerosisPhase 1NCT06566261
ABA-101 in Participants With Progressive Multiple Sclerosis
A Phase 1 study testing ABA-101 in people with Progressive Multiple Sclerosis, run by Abata Therapeutics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- ABA-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Sep 2024to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Cleveland Clinic Mellen Center
Cleveland, Ohio, 44195
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants With Progressive Multiple Sclerosis
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.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- ABA-101
- Keywords
- Progressive Multiple Sclerosis, Cell Therapy, Multiple Sclerosis, Treg, Regulatory T Cell
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABA-101Biological
ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy
| Study group | Role | What they receive |
|---|---|---|
| ABA-101 Dose 1 | Experimental | Low Dose ABA-101 Receives: Biological: ABA-101 |
| ABA-101 Dose 2 | Experimental | High Dose ABA-101 Receives: Biological: ABA-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (safety and tolerability)
Incidence of AEs through Day 29
Measured: Day of Treatment to End of DLT Evaluation Period (28 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start11 Sep 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential Escalating Dose Cohorts
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abata Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samantha Singer, President and CEO, Abata Therapeutics, MS MBA, Study director, Abata Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566261
- Sponsor's protocol ID
- 101-PMS-101
- Status last verified
- Jun 2025
- First submitted
- 20 Aug 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants With Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06566261
- Acronym / sponsor ID
- 101-PMS-101
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- Progressive Multiple Sclerosis, Cell Therapy, Multiple Sclerosis, Treg, Regulatory T Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Abata TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Escalating Dose Cohorts
| Arm | Type | Receives |
|---|---|---|
| ABA-101 Dose 1 | Experimental | Biological: ABA-101Low Dose ABA-101 |
| ABA-101 Dose 2 | Experimental | Biological: ABA-101High Dose ABA-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABA-101ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy | Biological | ABA-101 Dose 1, ABA-101 Dose 2 |
Primary outcome
Incidence of adverse events (safety and tolerability)
Time frame: Day of Treatment to End of DLT Evaluation Period (28 Days)
Incidence of AEs through Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Singer, President and CEO, Abata Therapeutics, MS MBA study director
Abata Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABA-101 in people with Progressive Multiple Sclerosis, run by Abata Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (safety and tolerability) (time frame: Day of Treatment to End of DLT Evaluation Period (28 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.