A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosis

This is an interventional treatment trial for Multiple Sclerosis focused on measuring alpha B-crystallin, immune tolerance Read More

Inclusion Criteria:

1. Clinically definite relapsing multiple sclerosis, according to the McDonald criteria
2. Abnormal MRI consistent with MS
3. Neurologically stable for at least one month
4. At least one clinical relapse over the previous year, or two relapses over the past two years, or one or more gadolinium-enhancing MRI lesion(s) at the time of screening.
5. An EDSS score less than 6
6. Body weight less than 130 kg
7. Use of adequate and stable contraception for 3 months prior to study initiation, during the course of the study and 30 days thereafter or must have undergone clinically documented total hysterectomy and/or oophorectomy, surgical sterilization, or be postmenopausal defined by amenorrhea for at least 12 months and confirmed with a FSH greater than 40 mIU/mL.
8. If patients claim abstinence as their method of contraception, they must be willing to agree to use condoms if they became sexually active from 14 days prior to the first dose of the study drug through 90 days beyond the conclusion of the study.
9. Being informed of the nature and aims of the study, and having given written consent to participate in this study in accordance with local laws and requirements
10. Being willing to comply with the protocol, and understand the information given, and the text of the consent form

Exclusion Criteria:

1. Primary progressive multiple sclerosis
2. Use of systemic corticosteroid treatment for more than 3 days within 30 days prior to screening
3. Plasmapheresis, or intravenous gammaglobulins less than 2 months before screening
4. Treatment with natalizumab less than one year before screening
5. Previous immunosuppressive treatment
6. Previous treatment with any leukocyte-targeting monoclonal antibody
7. Previous treatment with oral immune-modulatory agents (cladribine, fingolimod, laquinimod, fumarate)
8. Pregnant women, women planning to become pregnant and breastfeeding women
9. A history of or currently active clinically significant cardiac (including clinically significant ECG abnormalities in the opinion of the PI), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
10. ALT, AST and/or gamma-GT above 3 times the upper limit of normal
11. Serum creatinine above 1.5 times the upper limit of normal or an eGFR < 60 mL/min/1.73 m2
12. Hemoglobin < 7.0 mmol/l for females and < 8 mmol/l for males; leukocytes > 20*109/l or < 3.5*109/l; platelets < 125*109/l
13. SBP > 160 mmHg and/or DBP > 100 mmHg
14. Acute respiratory or other active infections
15. Fever (body temperature > 38.0 °C on day 1)
16. Blood donation or significant blood loss within 90 days of first study medication dosing
17. Plasma donation within 7 days of first study medication dosing
18. Having received blood or blood products in the last 6 months
19. Participation in another clinical study within 90 days of the start of this trial or planning participation in another clinical trial during this study or in the 4 weeks after last visit
20. Taking anti-coagulation or anti-platelet medication with the exception of NSAID's.
21. History of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake more than 28 units of alcohol), or psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
22. Vaccination with any vaccine within 4 weeks prior to dosing of the study medication
23. History of serious adverse reactions or hypersensitivity to any medicinal product
24. History of a malignancy other than skin cell basalioma 5 years prior to screening
25. Any physical condition that would, in the opinion of the investigator, place the patient at an unacceptable health risk or risk of injury or render the patient unable to meet the requirements of the protocol