Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis

A specific blood cell type called HLA-DR2 may be required in order for RTL1000 to work. For that reason, all subjects will be tested for HLA-DR2 and only those subjects who test positive (about 50%) will undergo further tests to determine if they meet inclusion and exclusion criteria.

Inclusion criteria:

Fulfill McDonald criteria for multiple sclerosis
Confirmed diagnosis of chronic progressive or relapsing-remitting multiple sclerosis
EDSS score of 0.0 to 6.5
No clinical exacerbations within the 8 weeks before administration of RTL1000
HLA-DR2 positive, as confirmed by study reference laboratory
Negative serum pregnancy test within 7 days of administration of RTL1000 and negative urine pregnancy test on Day 0 for all women of childbearing potential
Agreement of sexually active men and women of childbearing potential to practice a medically-approved form of contraception
Capable of and willing to provide written informed consent

Exclusion Criteria:

Exposure to alemtuzumab or dacluzimab any time in the 6 months before administration of RTL1000
Exposure to natalizumab or other drugs targeting alpha-4 integrin in the 6 months before RTL1000 administration or more than 3 doses of natalizumab or these drugs at any time.
Any prior exposure to RTL1000
Exposure to other MS disease-modifying drugs (e.g., recombinant interferon beta and glatiramer acetate), immunosuppressant agents, or systemic corticosteroids (other than replacement doses) within the 4 weeks prior to RTL1000 administration
Exposure to chemotherapeutic immunosuppressants, including azathioprine, mycophenolate mofetil, methotrexate, cladribine, mitoxantrone, or cyclophosphamide, during the six months prior to administration of RTL1000
Total lymphoid irradiation or bone marrow transplantation at any time
Known or suspected allergy to gadolinium
Contraindication to MRI (e.g., subject has a pacemaker or other contraindicated implanted metal devices or has claustrophobia that cannot be medically managed)
Clinically significant abnormalities in laboratory findings for hematologic, hepatic, and renal function at screening.
Significant medical diseases or conditions, including poorly controlled hypertension, cardiovascular disease, inflammatory disorders, immunodeficiency (e.g., HIV infection), renal failure, liver dysfunction, cancer (except treated basal cell carcinoma), or active infection.
History of, or current, psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
History of alcohol or drug abuse likely to interfere with ability to comply with protocol requirements
Pregnancy or lactation