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 range18 Years â 65 Years
SexALL
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Inclusion criteria
â. Clinical diagnosis of MS with evidence of PPMS or SPMS according to 2025 McDonald criteria.
â. Expanded Disability Status Scale (EDSS) range â„ 2.5 to †6.5.
â. Evidence of clinical disability progression within 2 years prior to enrollment.
â. Documented presence of CSF-restricted OCBs and/or elevated IgG index and/or Îș free light chain.
â. Males and females â„ 18 and †65 years of age at time of consent.
â. Evidence of adequate organ function
â. Women of child bearing potential have a negative pregnancy test at screening.
â. Contraceptive use by all participants while on study.
Exclusion criteria
â. MS clinical stability on disease modifying therapy.
â. Clinical relapse of MS in the 1 year prior to study entry.
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
â. Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity.
â. Prior treatment with CAR-T or gene therapy product directed at any target.
â. Prior treatment with mitoxantrone, cladribine (or other chemotherapies), or alemtuzumab within 2 years prior to TRX319 dose.
â. 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.
â. 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.
â. Serologic status reflecting active hepatitis B or C infection.