Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07477639

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

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
39 (estimated)
Sponsor
Tr1X, Inc. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
BIOLOGICALTRX319TRX319 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.
DRUGBendamustineAdministration of bendamustine prior to TRX319 infusion

Timeline

Start date
2026-03-01
Primary completion
2028-08-01
Completion
2029-01-01
First posted
2026-03-17
Last updated
2026-03-19

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07477639. Inclusion in this directory is not an endorsement.