Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis (NCT07477639) | Clinical Trial Compass
RecruitingPhase 1/2
Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
United States39 participantsStarted 2026-03
Plain-language 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 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Women of child bearing potential have a negative pregnancy test at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety and tolerability of TRX319 infusion in subjects with Primary Progressive or Secondary Progressive Multiple Sclerosis.
Timeframe: From baseline until 12 months post TRX319 Infusion
. Contraceptive use by all participants while on study.
Exclusion criteria
. 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.
. 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.