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Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

NCT07477639 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

TRX319

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.

DRUG

Bendamustine

Administration of bendamustine prior to TRX319 infusion

Sponsors & Collaborators

  • Tr1X, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-08-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477639 on ClinicalTrials.gov