Durham, NCNCT07477639Now EnrollingIRB Ready

Primary Progressive Multiple Sclerosis Clinical Trial in Durham, NC

Access cutting-edge primary progressive multiple sclerosis treatment through this phase 1/2 clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Tr1X, Inc.

Quick Self-Assessment

See if you qualify for this Durham location

Preparing your pre-screening questions…

Expert Care in Durham

Access primary progressive multiple sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related primary progressive multiple sclerosis treatment provided free

Apply for This Durham Location

Check if you qualify for this primary progressive multiple sclerosis clinical trial in Durham, NC

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Durham site if eligible
  4. 4Begin participation

About This Primary Progressive Multiple Sclerosis Study in Durham

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.

Sponsor: Tr1X, Inc.

Who Can Participate

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.
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 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.
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT07477639) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Progressive Multiple Sclerosis Treatment Options in Durham, NC

If you're searching for primary progressive multiple sclerosis treatment options in Durham, NC, this clinical trial (NCT07477639) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced primary progressive multiple sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all primary progressive multiple sclerosis clinical trials near you to find additional studies recruiting in your area.

More Multiple Sclerosis Trials in Durham, NC

See all multiple sclerosis clinical trials recruiting in Durham — not just this study.

Browse Multiple Sclerosis Trials in Durham →

Browse More Trials by Condition

Multiple Sclerosis TrialsAll Conditions →

Ready to Join in Durham?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Durham, NC