drugset / Trial / NCT07020715
A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis
Phase 2
Not yet recruiting
14 enrolled
University Hospital, Antwerp
Fundació Institut Germans Trias i Pujol · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2029-09-30
- Completion
- 2029-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tolerogenic dendritic cells | Cell therapy | 1.5e+07 cells | Intrathecal |