drugset / Trial / NCT07020715

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

NCT07020715

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

EvaluationDrugModalityDoseRoute
Subject tolerogenic dendritic cells Cell therapy 1.5e+07 cells Intrathecal

Indications