RecruitingPhase 1Phase 2NCT07477639

Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

A Phase 1/2a, Open-Label, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX319 in Subjects With Primary or Secondary Progressive Multiple Sclerosis

Sponsor

Tr1X, Inc.

Enrollment

39 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Primary Progressive Multiple Sclerosis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called TRX319 — a type of immune cell therapy — for people with progressive multiple sclerosis (MS), specifically primary progressive MS (PPMS) or secondary progressive MS (SPMS), where the disease keeps getting worse rather than coming in episodes. **You may be eligible if...** - You have been diagnosed with PPMS or SPMS according to current MS criteria - Your disability level falls in a moderate range on a standard MS disability scale - Your MS has been getting worse over the past 2 years - You are between 18 and 65 years old - Lab tests show certain immune markers (proteins in spinal fluid) - You are up to date on the chickenpox (varicella) vaccine or have immune protection **You may NOT be eligible if...** - Your MS has been stable on medication - You had an MS relapse (flare) in the past year - Your symptoms might be caused by something other than MS - You previously received CAR-T cell therapy or gene therapy - You received certain chemotherapy drugs (like mitoxantrone or alemtuzumab) within the past 2 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALTRX319

TRX319 is an investigational research cell therapy that may treat and provide long term relief to individuals suffering from Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis.

DRUGBendamustine

Administration of bendamustine prior to TRX319 infusion