Autologous T Cell Vaccine (TCV) for Multiple Sclerosis

Study Overview
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Brief Summary
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This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).

Detailed Description
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A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Biological: Tovaxin Autologous T cell vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 55 years old Presence of myelin reactive T cells at screening Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space Diagnosis of MS within the past 10 years according to the McDonald criteria (2005) Baseline EDSS score between 0 and 5.5 inclusively Exclusion Criteria: Unable to produce T cell vaccine Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS Planned pregnancy, currently pregnant, or breastfeeding Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tovaxin Autologous T cell vaccine<br>2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells | Biological: Tovaxin Autologous T cell vaccine<br>* subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24<br>|
| Placebo Comparator: Placebo<br>2.0 mL subcutaneous injections without autologous myelin reactive T cells | Biological: Placebo<br>* subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2b Tovaxin, Clinically Isolated Syndrome (CIS), Relapse-Remitting Multiple Sclerosis (RR-MS)