A Clinical Trial Evaluating the Safety and Efficacy of Myelin-peptide Loaded tolDC as Treatment for MS
Summary
The investigators propose to design and conduct a phase II clinical trial to treat patients with multiple sclerosis (MS) by vaccination with tolerogenic dendtritic cells (tolDC), generated using Good Manufacturing Practices (GMP). Hereby, the investigators want to demonstrate the efficacy of administrating clinical-grade vitamin D3-treated tolDC loaded with myelin-derived peptides to treat a well-defined population of MS patients. 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
Timeline
- Start
- 2025-04-30
- Primary completion
- 2025-04-30
- Completion
- 2027-10-29
Outcome
Outcome not reported
Stopped (Business): “Feasibility issues, insufficient funding, delays due transition to CTIS.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tolerogenic dendritic cells | Cell therapy | 1.5e+07 cells | Intravenous |
| Comparator | Glatiramer Acetate | Small molecule | — | — |
| Comparator | Interferon-beta | Protein / enzyme biologic | — | — |
| Comparator | Ozanimod | Small molecule | — | — |
| Comparator | Ponesimod | Small molecule | — | — |
| Comparator | Teriflunomide | Small molecule | — | — |
| Comparator | dimethyl fumarate | Unknown | — | — |