• A Clinical Trial Evaluating the Safety and Efficacy of Myelin-peptide Loaded tolDC as Treatment for MS

  NCT06715605

  WithdrawnInterventionalPhase 2Updated Aug 17, 2025
• Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)

  NCT02903537

  Unknown statusInterventionalPhase 1Updated Jul 7, 2023
• A "negative"dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial

  NCT02618902

  CompletedInterventionalPhase 1Updated Dec 9, 2024
• Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis

  NCT04530318

  Active, not recruitingInterventionalPhase 2Updated Feb 19, 2026
• Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B

  NCT02283671

  CompletedInterventionalPhase 1Updated Feb 27, 2020
• Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

  NCT00587691

  CompletedInterventionalPhase 1Phase 2Updated Jan 11, 2017

ClinicalTrials.gov ID

NCT07020715

Lead Sponsor

University Hospital, AntwerpOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

14Estimated

Last Update Posted

May 5, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Sep 30, 2029Estimated

Completion Date

Oct 30, 2029Estimated

Official Title

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

Brief 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.

Detailed Description

This is an open-label, self-controlled, multi-center phase IIa clinical trial designed to evaluate the proof-of-concept for both efficacy and safety of tolDC-based therapy. The primary objective is to determine whether treatment with tolDC is effective (using a surrogate primary outcome-change in EDSS score) and safe (the occurrence and severity of adverse events). Secondary evaluations will include the clinical outcomes (assessed using 9HPT, SDMT and number and severity of relapses) and MRI-based markers. Participants will serve as their own controls, with data from 24 weeks pre-treatment period (documented by their neurologist). Following six tolDC administrations, a 24-weeks follow-period will take place. Furthermore, participants can enroll voluntarily into an optional additional follow-up phase of 52 weeks. Completion of screening assessments and confirmation of eligibility criteria should take no longer than 8 weeks.

• Multiple Sclerosis

• Tolerogenic dendritic cells (tolDC)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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
• 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
• Drug or alcohol abuse
• Inability to undergo MRI assessments
• History of or actual signs of immunodeficiency or malignancies (with the exception of treated basal cell carcinoma)
• Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease that could impact safety or outcome measures.
• Active or chronic infection with hepatitis B, C, HIV, syphilis or tuberculosis
• Splenectomy
• Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Fundació Institut Germans Trias i PujolOTHER

cramrot@gmail.com0034 93 497 84 33