Autologous T Cell Vaccine (TCV) for Multiple Sclerosis (TERMS)

Opexa Therapeutics

Status and phase: Completed; Phase 2

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Biological: Placebo; Biological: Tovaxin Autologous T cell vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245622

2005-00

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Tovaxin Autologous T cell vaccine

Experimental group

Description:

2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells

Treatment:

Biological: Tovaxin Autologous T cell vaccine

Placebo

Placebo Comparator group

Description:

2.0 mL subcutaneous injections without autologous myelin reactive T cells

Treatment:

Biological: Placebo