TRX319 treatment for people with primary or secondary progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 trial will enroll adults with primary or secondary progressive MS who meet criteria including EDSS 2.5–6.5, recent clinical progression, and CSF markers of immune activity. Participants may receive up to three administrations of TRX319 over a one-year period, with some randomized or assigned to receive bendamustine pre-conditioning to see if it enhances treatment effect. Safety, optimal dose, and biological activity will be monitored using blood tests, MRI scans, and lumbar punctures. The trial is being conducted at the University of Kansas Medical Center and Washington University in St. Louis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clinical diagnosis of MS with evidence of PPMS or SPMS according to 2025 McDonald criteria.
2. Expanded Disability Status Scale (EDSS) range ≥ 2.5 to ≤ 6.5.
3. Evidence of clinical disability progression within 2 years prior to enrollment.
4. Documented presence of CSF-restricted OCBs and/or elevated IgG index and/or κ free light chain.
5. Males and females ≥ 18 and ≤ 65 years of age at time of consent.
6. Evidence of adequate organ function
7. Women of child bearing potential have a negative pregnancy test at screening.
8. Contraceptive use by all participants while on study.
9. Participants must be able to understand, consent, and be willing and able to complete all specified procedures and visits.
10. 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.
11. Participants must be willing to refrain from donating blood for 1 year after TRX319 infusion.

Exclusion Criteria:

1. MS clinical stability on disease modifying therapy.
2. Clinical relapse of MS in the 1 year prior to study entry.
3. Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity.
4. Prior treatment with CAR-T or gene therapy product directed at any target.
5. Prior treatment with mitoxantrone, cladribine (or other chemotherapies), or alemtuzumab within 2 years prior to TRX319 dose.
6. 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.
7. 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.
8. Serologic status reflecting active hepatitis B or C infection.
9. Positive serology for human immunodeficiency virus (HIV).
10. History of progressive multifocal leukoencephalopathy.
11. 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.
12. Primary immunodeficiency as defined by a known genetic disorder.
13. History of splenectomy.
14. Impaired cardiac function or clinically significant cardiac disease.
15. Previous or concurrent malignancy.
16. Prior organ transplant, or allogeneic hematopoietic stem cell transplantation or recipient of peripheral blood products \< 3 years prior to TRX319 infusion.
17. Major surgery within 4 weeks prior or planned within 4 weeks after TRX319 administration.
18. History of any other neurologic disorder or medical condition the Investigator considers would increase the risk for the participant, including seizure disorders.
19. Life-threatening allergies, hypersensitivity, or documented intolerance to TRX319 drug product excipients.
20. 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).
21. 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.

Where it's running

• UC San Diego
  La Jolla, California, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Washington University, St. Louis
  St Louis, Missouri, United States Recruiting
• Mt. Sinai
  New York, New York, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Tr1X Clinical Trials
• Email: Tr1xClinicalTrials@Tr1x.bio
• Phone: 858-283-7879

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.