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

Study acronym: MS-tolDC_2a
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion pushed from May 30, 2027 to Sep 30, 2029
    • Start date: Mar 1, 2026 to Jul 1, 2026
    • Study completion pushed from Oct 30, 2028 to Oct 30, 2029
    v3
  2. Primary completion date: Dec 1, 2025 to May 30, 2027v2 Show 7 more changesShow less
    • Start date: Dec 1, 2025 to Mar 1, 2026
    • Primary endpoints revised (2)
    • Enrollment target: 10 to 14
    • Study completion date: Oct 29, 2027 to Oct 30, 2028
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 20 words
    • Site contacts updated at 1 of 2 sites
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07020715
Lead Sponsor University Hospital, Antwerp
Collaborators: Fundació Institut Germans Trias i Pujol
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov