A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis

Exclusion Criteria

• •Previous treatment with alemtuzumab, autologous hematopoietic stem cell transplantation or cladribine in the past 3 years.
• •Prior treatment with any investigational agent within 3 months, or 5 half-lives, whichever is longer.
• •Current and ongoing treatment with an approved DMT for MS
• •Treatment with S1P receptor modulators, natalizumab, dimethylfumarate, teriflunomide within the last 3 months prior to study enrolment; last treatment with B cell depleting monoclonal antibodies at least 6 months prior to enrollment and normal CD19 B cell counts at time of enrollment
• •Pregnancy or planning pregnancy in the next 12 months and breast feeding
• •Drug or alcohol abuse
• •Inability to undergo MRI assessments
• •History of or actual signs of immunodeficiency or malignancies (with the exception of treated basal cell carcinoma)
• •Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease that could impact safety or outcome measures.
• •Active or chronic infection with hepatitis B, C, HIV, syphilis or tuberculosis
• •Splenectomy
• •Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.