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

Korábbi kezelés

• 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
• Drug or alcohol abuse
• Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease that could impact safety or outcome measures.

Más betegség

• History of or actual signs of immunodeficiency or malignancies (with the exception of treated basal cell carcinoma)
• Active or chronic infection with hepatitis B, C, HIV, syphilis or tuberculosis
• Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.

Laborértékek

• 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

Egyéb

• Pregnancy or planning pregnancy in the next 12 months and breast feeding
• Inability to undergo MRI assessments
• Splenectomy

• Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit
• Diagnosis of MS according to the 2017 McDonald Criteria or more recent criteria
• Progressive MS by 2014 Lublin MS phenotypic criteria
• EDSS 2,0 - ≤7,5
• No clinical evidence of relapses in the past 2 years
• Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
• Appropriate venous access
• Use of adequate contraceptive measures or not of childbearing potential