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New treatment option for Primary Progressive Multiple Sclerosis
Official title Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT07477639
What this study is testing
What is TRX319?
TRX319 is an investigational medicine, being studied as a potential treatment for primary progressive multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
- 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.
- 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.
- people that are pregnant, breast feeding or aim to become pregnant during the study period (people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States; St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.