TRX319 for Adults With Primary or Secondary Progressive Multiple Sclerosis
Tests TRX319, with or without bendamustine, in adults with progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
Key facts
- Where
- Cincinnati, Durham, Kansas City, La Jolla, New York, Rochester, Seattle, and St Louis, United StatesSee the 8 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07477639, who can take part
Where in United States
- University of CincinnatiCincinnati, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- UC San DiegoLa Jolla, United StatesTaking people
- Mt. SinaiNew York, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Providence SwedishSeattle, United StatesTaking people
- Washington University St. LouisSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tr1X, Inc.
- Trial code
- NCT07477639
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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:
* 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.
Inclusion: 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; 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.
Exclusion: Clinical relapse of MS in the 1 year prior to study entry; 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; 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; MS clinical stability on disease modifying therapy; Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity; 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; 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; 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; 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).