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

NCT01414634 | Completed Phase 1 Results DMC

• 1 other identifier: inims-oo1
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (2)

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

  12 months

• Number of Adverse Events

  3 months after treatment

Study Arms (8)

ETIMS 1x10^3

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^3 cells.

Biological: ETIMS

ETIMS 1x10^5

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^5 cells.

Biological: ETIMS

ETIMS 1x10^7

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^7 cells.

Biological: ETIMS

ETIMS 1x10^8

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^8 cells.

Biological: ETIMS

ETIMS 5x10^8

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 5x10\^8 cells.

Biological: ETIMS

ETIMS 1x10^9

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^9 cells.

Biological: ETIMS

ETIMS 2.5x10^9

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 2.5x10\^9 cells.

Biological: ETIMS

ETIMS 3x10^9

EXPERIMENTAL

The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 3x10\^9 cells.

Biological: ETIMS

Interventions

ETIMS BIOLOGICAL

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

ETIMS 1x10^3; ETIMS 1x10^5; ETIMS 1x10^7; ETIMS 1x10^8; ETIMS 1x10^9; ETIMS 2.5x10^9; ETIMS 3x10^9; ETIMS 5x10^8

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 55 years.
• Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria
• EDSS score between 1 and 5.5.
• Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone)
• 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.
• Disease duration ≤ 5 years (Only Phase II)

You may not qualify if:

• Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria.
• Abnormal screening/baseline blood tests exceeding any of the limits defined
• Pregnant or breast-feeding female.
• History or signs of immunodeficiency.
• Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
• Splenectomy
• History of HIV or positive HIV antibody testing
• Serology indicating active Hepatitis B or C infection.
• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Related Publications (1)

• Lutterotti A, Yousef S, Sputtek A, Sturner KH, Stellmann JP, Breiden P, Reinhardt S, Schulze C, Bester M, Heesen C, Schippling S, Miller SD, Sospedra M, Martin R. Antigen-specific tolerance by autologous myelin peptide-coupled cells: a phase 1 trial in multiple sclerosis. Sci Transl Med. 2013 Jun 5;5(188):188ra75. doi: 10.1126/scitranslmed.3006168.

  PMID: 23740901 RESULT

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Roland Martin
• Organization: Neuroimmunology and MS Research, Department of Neurology, University Hospital Zürich, 8091 Zürich, Switzerland

roland.martin@usz.ch

044 255 11 25

Study Officials

• Christoph Heesen, MD

  Department of Neurology, University Clinic Eppendorf (UKE)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 11, 2011
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 4, 2015
• Results First Posted: April 8, 2015

Record last verified: 2015-04