Primary Progressive Multiple SclerosisPhase 1/2IMPACT-MSNCT07477639
Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
A Phase 1/2 study testing TRX319 and Bendamustine in people with Primary Progressive Multiple Sclerosis and Secondary Progressive Multiple Sclerosis (SPMS), run by Tr1X, Inc. at 8 sites in United States.
Trial summary
The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS. The main questions the trial aims to answer are the following: Is TRX319 safe when administered to patients with progressive forms of MS? At what… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis (SPMS), Multiple Sclerosis
- What is being tested?
- TRX319 and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Mar 2026to Jan 2029
- Phase
- Phase 1/2
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MS with evidence of PPMS or SPMS according to 2025 McDonald criteria.
- Expanded Disability Status Scale (EDSS) range ≥ 2.5 to ≤ 6.5.
- Evidence of clinical disability progression within 2 years prior to enrollment.
- Documented presence of CSF-restricted OCBs and/or elevated IgG index and/or κ free light chain.
- Males and females ≥ 18 and ≤ 65 years of age at time of consent.
- Evidence of adequate organ function
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- Women of child bearing potential have a negative pregnancy test at screening.
- Contraceptive use by all participants while on study.
- Participants must be able to understand, consent, and be willing and able to complete all specified procedures and visits.
- Positive varicella zoster virus titer. Participants who test seronegative for varicella zoster virus IgG antibodies need to complete vaccination ≥ 4 weeks prior to TRX319 infusion.
- Participants must be willing to refrain from donating blood for 1 year after TRX319 infusion.
Who cannot join
- MS clinical stability on disease modifying therapy.
- Clinical relapse of MS in the 1 year prior to study entry.
- Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity.
- Prior treatment with CAR-T or gene therapy product directed at any target.
- Prior treatment with mitoxantrone, cladribine (or other chemotherapies), or alemtuzumab within 2 years prior to TRX319 dose.
- Prior treatment with CD20-depleting antibodies within 3 months and prior treatment with Bruton's tyrosine kinase inhibitor (BTKi) and sphingosine 1 phosphate (S1P) modulators within 1 month of TRX319 dose.
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- Plan to or have received live, attenuated vaccines less than 4 weeks (28 days) prior to TRX319 infusion, and other vaccines less than 2 weeks (14 days) prior to TRX319 infusion.
- Serologic status reflecting active hepatitis B or C infection.
- Positive serology for human immunodeficiency virus (HIV).
- History of progressive multifocal leukoencephalopathy.
- Untreated active, or active with documented completed treatment but without a negative chest X-ray that shows no evidence of active tuberculosis, or latent tuberculosis.
- Primary immunodeficiency as defined by a known genetic disorder.
- History of splenectomy.
- Impaired cardiac function or clinically significant cardiac disease.
- Previous or concurrent malignancy.
- Prior organ transplant, or allogeneic hematopoietic stem cell transplantation or recipient of peripheral blood products < 3 years prior to TRX319 infusion.
- Major surgery within 4 weeks prior or planned within 4 weeks after TRX319 administration.
- History of any other neurologic disorder or medical condition the Investigator considers would increase the risk for the participant, including seizure disorders.
- Life-threatening allergies, hypersensitivity, or documented intolerance to TRX319 drug product excipients.
- Subjects that are pregnant, breast feeding or aim to become pregnant during the study period (Subjects must agree to use a highly effective method of contraception).
- Serious and/or uncontrolled medical condition that, in the Investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Study Team contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Kristine Suder Coordinator, 513-558-3920, suderkl@ucmail.uc.edu
- Recruiting
Duke University
Durham, North Carolina, 27710
Jessica Franceschelli Coordinator, 919-613-1107, jessica.franceschelli@duke.edu
Suma Shah
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sharon Lynch, MD, 913-588-6980, SLYNCH@kumc.edu
- Recruiting
UC San Diego
La Jolla, California, 92037
Vicky Vardouniotis, 858-246-1249, vvardouniotis@health.ucsd.edu
Jennifer Graves, MD
- Recruiting
Mt. Sinai
New York, New York, 10029
Sarah Myoung, MBS, 2122413391 ext. 43391
Fred Lublin, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55912
Lisa Roemer, 507-293-9754, roemer.lisa@mayo.edu
Michel Toledano, MD
- Recruiting
Providence Swedish
Seattle, Washington, 98122
Isabella Bueno, 206-320-3070, isabella.bueno1@swedish.org
Pavle Repovic, MD, PhD
- Recruiting
Washington University, St. Louis
St Louis, Missouri, 63110
Susan Sommer, 314-362-3293, foxs@wustl.edu
About this study
Official title: A Phase 1/2a, Open-Label, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX319 in Subjects With Primary or Secondary Progressive Multiple Sclerosis
The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS.
The main questions the trial aims to answer are the following:
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- Is TRX319 safe when administered to patients with progressive forms of MS?
- At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS?
- Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and/or secondary progressive MS?
Participants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.
- Conditions
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis (SPMS), Multiple Sclerosis, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive
- Being tested
- TRX319, Bendamustine
- Keywords
- TRX319-01, IMPACT-MS, Tr1X, Multiple Sclerosis, MS, Autoimmune, Impact MS, PPMS, SPMS, Primary Progressive, Secondary Progressive
- 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.
TRX319Biological
TRX319 is an investigational research cell therapy that may treat and provide long term relief to individuals suffering from Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis.
BendamustineDrug
Administration of bendamustine prior to TRX319 infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose Level 1 Receives: Biological: TRX319 |
| Cohort 1A | Experimental | Dose Level 1 with pre-conditioning Receives: Biological: TRX319; Drug: Bendamustine |
| Cohort 2 | Experimental | Dose level 2 Receives: Biological: TRX319 |
| Cohort 2A | Experimental | Dose Level 2 with pre-conditioning Receives: Biological: TRX319; Drug: Bendamustine |
| Cohort 3 | Experimental | Dose Level 3 Receives: Biological: TRX319 |
| Cohort 3A | Experimental | Dose level 3 with pre-conditioning Receives: Biological: TRX319; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of TRX319 infusion in subjects with Primary Progressive or Secondary Progressive Multiple Sclerosis.
- Number of participants with severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
- Rate of Adverse Events of Special Interest (AESIs) in participants
- The safety of TRX319 determined by negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months
Measured: From baseline until 12 months post TRX319 Infusion
Secondary outcomes (3)
To characterize target engagement via reduction of Oligoclonal bands (OCB) and/or normalization of cerebral spinal fluid (CSF) Immunoglobulin G (IgG) index
- Reduction of OCB in CSF
- Reduction and/or normalization of CSF IgG index
Measured: From baseline until 12 months post TRX319 Infusion
To evaluate the effects of TRX319 on disease progression/reactivation by gadolinium-enhancing MRI
No increase in gadolinium-enhanced T1-weighted lesions and no new or enlarging T1- or T2-weighted lesions in brain and cervical spinal cord
Measured: From baseline until 12 months post TRX319 Infusion
To evaluate disease response, as measured by the Neurostatus Expanded Disability Status Scale (EDSS)
Measure of disease response based on change in disability and walking score at Weeks 12, 24, 36, and 48.
Measured: From baseline to approximately 12 months post TRX319 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Mar 2026
- Primary completionAug 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tr1X, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477639
- Sponsor's protocol ID
- TRX319-01
- Acronym
- IMPACT-MS
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No