The investigators propose to design and conduct a phase IIa clinical trial to treat patients with progressive forms of multiple sclerosis (MS) by vaccination with tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practices (GMP). Hereby, the investigators want to demonstrate the efficacy and safety of administrating clinical-grade vitamin D3-treated tolDC loaded with myelin-derived peptides to patients with progressive forms of MS. In vitro generation of dedicated and stable immunomodulatory DC followed by in vitro loading of antigens to ensure tolerance and safety of DC-directed therapy is a promising strategy with the potential to induce long term tolerance.
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
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
University Hospital, Antwerp
Lead sponsor
Fundació Institut Germans Trias i Pujol
Collaborator