Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells

Universitätsklinikum Hamburg-Eppendorf9 enrolled

Overview

Open-label, single center, phase I clinical trial to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS patients.

Open-label, single center, phase I dose-escalation study to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of a single infusion of autologous peripheral blood mononuclear cells chemically coupled with seven myelin peptides (MOG1-20, MOG35-55, MBP13-32, MBP83-99, MBP111-129, MBP146-170, and PLP139-154) in Multiple Sclerosis patients who were off-treatment for standard therapies. Neurological, magnetic resonance imaging, laboratory, and immunological examinations were performed to assess the safety, tolerability, and in vivo mechanisms of action of this regimen.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ETIMSBIOLOGICAL

injection of peptide-coupled PBMC by i.v. infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Between the ages of 18 and 55 years. 2. Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria 3. EDSS score between 1 and 5.5. 4. Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone) 5. Patients are able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care. 6. Disease duration ≤ 5 years (Only Phase II) Exclusion Criteria: 1. Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria. 2. Abnormal screening/baseline blood tests exceeding any of the limits defined 3. Pregnant or breast-feeding female. 4. History or signs of immunodeficiency. 5. Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease. 6. Splenectomy 7. History of HIV or positive HIV antibody testing 8. Serology indicating active Hepatitis B or C infection. 9. Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame: 12 months

Number of Adverse Events

Time frame: 3 months after treatment

Data from ClinicalTrials.gov

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