Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

Study acronym: IMPACT-MS
StatusRecruiting
PhasePhase 1/2
SponsorTr1X, Inc.
Started

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Record History

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  1. Trial sites expanded: 2 → 8 locations
    • Start date changed from estimate of Mar 2026 to Mar 1, 2026
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Study sites: 1 to 2v2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07477639
Lead Sponsor Tr1X, Inc.
Conditions
(from sponsor)		 Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis (SPMS), Multiple Sclerosis, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive
Related terms Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov