Tests vitamin D-treated immune cells in progressive multiple sclerosis
Tests tolerogenic dendritic cells, loaded with myelin peptides, in people with progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis
Key facts
- Where
- Edegem, BelgiumSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07020715, who can take part
Where in Belgium
- Universitair Ziekenhuis AntwerpenEdegem, BelgiumNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Antwerp
- Trial code
- NCT07020715EU 2025-522040-40-01
- Record updated
- 5 May 2026
- Original description
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.Read full original descriptionShow less
An Autologous and Antigen-specific Cell-based Therapy of Vitamin D3-treated and Myelin-derived Peptide Loaded Tolerogenic Dendritic Cells in Subjects With Progressive Forms of Multiple Sclerosis: a Phase IIa, Open-label, Self-controlled, Multi-center Clinical Trial
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.
Inclusion: 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.
Exclusion: 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; 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; 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; Inability to undergo MRI assessments; Splenectomy.