Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• TRX319 — BIOLOGICAL
  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.
• Bendamustine — DRUG
  Administration of bendamustine prior to TRX319 infusion

Study Details

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.

Key Dates

Start date

Mar 31, 2026

Status verified

Mar 2026

Primary completion

Aug 31, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

39 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Dose Level 1
• Experimental: Cohort 1A
  Dose Level 1 with pre-conditioning
• Experimental: Cohort 2
  Dose level 2
• Experimental: Cohort 2A
  Dose Level 2 with pre-conditioning
• Experimental: Cohort 3
  Dose Level 3
• Experimental: Cohort 3A
  Dose level 3 with pre-conditioning

Primary Outcome Measure

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

Central Contacts

• Tr1X Clinical Trials
  858-283-7879
  [email protected]
• Study Team
  [email protected]

Locations (2)

Find similar trials in Kansas City, KS

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