Actively Recruiting
Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
Led by Tr1X, Inc. · Updated on 2026-03-19
39
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of multiple sclerosis with primary progressive or secondary progressive form according to 2025 McDonald criteria
- Expanded Disability Status Scale (EDSS) score between 2.5 and 6.5
- Evidence of disability progression within 2 years before enrollment
- Presence of cerebrospinal fluid (CSF) restricted oligoclonal bands or elevated IgG index or kappa free light chain
- Male or female aged 18 to 65 years at consent
- Adequate organ function
- Negative pregnancy test for women of childbearing potential at screening
- Use of contraception during the study
- Ability to understand and complete all study procedures and visits
- Positive varicella zoster virus titer or completed vaccination at least 4 weeks before TRX319 infusion if seronegative
- Willingness to avoid blood donation for 1 year after TRX319 infusion
You will not qualify if you...
- Stable multiple sclerosis on disease modifying therapy
- Clinical relapse of multiple sclerosis within 1 year before study entry
- Other diseases explaining the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity
- Prior treatment with CAR-T or gene therapy
- Treatment with mitoxantrone, cladribine, other chemotherapies, or alemtuzumab within 2 years before TRX319
- Treatment with CD20 depleting antibodies within 3 months or Bruton's tyrosine kinase inhibitors or sphingosine 1 phosphate modulators within 1 month before TRX319
- Receipt of live attenuated vaccines within 4 weeks or other vaccines within 2 weeks before TRX319
- Active hepatitis B or C infection
- Positive HIV serology
- History of progressive multifocal leukoencephalopathy
- Untreated or active tuberculosis without a negative chest X-ray
- Primary immunodeficiency
- History of splenectomy
- Impaired cardiac function or serious cardiac disease
- Previous or current cancer
- Prior organ transplant or hematopoietic stem cell transplantation or peripheral blood product receipt within 3 years before TRX319
- Major surgery within 4 weeks before or planned within 4 weeks after TRX319
- Other neurologic or medical conditions increasing risk
- Severe allergies or intolerance to TRX319 components
- Pregnancy, breastfeeding, or plans to become pregnant during the study
- Serious uncontrolled medical conditions increasing safety risk or interfering with the study procedures
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
2
Washington University, St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
T
Tr1X Clinical Trials
CONTACT
S
Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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