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TRX319 for Primary or Secondary Progressive Multiple Sclerosis

This study is testing an investigational cell therapy called TRX319, sometimes given with another drug called Bendamustine, for people with primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS). Researchers want to see if TRX319 is safe and how well it works to treat these types of MS. They are also trying to figure out the best dose and if Bendamustine helps TRX319 work better. You may be eligible if you are 18 to 65 years old, have a diagnosis of PPMS or SPMS, and show signs of disability progression. The study will also check for specific markers in your spinal fluid (CSF-restricted OCBs and/or elevated IgG index and/or κ free light chain). The study aims to enroll 39 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is not specified if it's randomized or blinded, and the phase is not specified.
What's involved
Participants will be on study for up to one year and may receive up to three administrations of TRX319.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability to TRX319 will be assessed from the start of the study until 12 months after your last TRX319 infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07477639

Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Tr1X, Inc.
~39 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:TRX319Bendamustine

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the safety and tolerability of TRX319 infusion in subjects with Primary Progressive or Secondary Progressive Multiple Sclerosis.
Measured over From baseline until 12 months post TRX319 Infusion

Conditions

Primary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis (SPMS)
Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Multiple Sclerosis (MS) Secondary Progressive

Explore related trials

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NCT07477639

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Kansas Medical Center

    Kansas City, Kansasstudy coordinator listed

    Recruiting

  • Washington University, St. Louis

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Tr1X Clinical Trials
[email protected]
858-283-7879
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • To assess the safety and tolerability of TRX319 infusion in subjects with Primary Progressive or Secondary Progressive Multiple Sclerosis.From baseline until 12 months post TRX319 Infusion

    * Number of participants with severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) * Rate of Adverse Events of Special Interest (AESIs) in participants * The safety of TRX319 determined by negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months