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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
Administration of bendamustine prior to TRX319 infusion
University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGWashington University, St. Louis
St Louis, Missouri, United States
RECRUITINGTo assess the safety and tolerability of TRX319 infusion in subjects with Primary Progressive or Secondary Progressive Multiple Sclerosis.
* Number of participants with severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) * Rate of Adverse Events of Special Interest (AESIs) in participants * The safety of TRX319 determined by negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months
Time frame: From baseline until 12 months post TRX319 Infusion
To characterize target engagement via reduction of Oligoclonal bands (OCB) and/or normalization of cerebral spinal fluid (CSF) Immunoglobulin G (IgG) index
* Reduction of OCB in CSF * Reduction and/or normalization of CSF IgG index
Time frame: From baseline until 12 months post TRX319 Infusion
To evaluate the effects of TRX319 on disease progression/reactivation by gadolinium-enhancing MRI
No increase in gadolinium-enhanced T1-weighted lesions and no new or enlarging T1- or T2-weighted lesions in brain and cervical spinal cord
Time frame: From baseline until 12 months post TRX319 Infusion
To evaluate disease response, as measured by the Neurostatus Expanded Disability Status Scale (EDSS)
Measure of disease response based on change in disability and walking score at Weeks 12, 24, 36, and 48.
Time frame: From baseline to approximately 12 months post TRX319 infusion
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