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

Launched by UNIVERSITY HOSPITAL, ANTWERP · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with multiple sclerosis (MS) using specially prepared immune cells called tolerogenic dendritic cells (tolDC). These cells are created with vitamin D3 and designed to help the immune system recognize and tolerate myelin, the protective covering of nerves that MS attacks. The goal is to see if this treatment can be both safe and effective for patients with progressive forms of MS.

To be eligible for this trial, participants need to be between 18 and 65 years old and must have a confirmed diagnosis of progressive MS. They should not have experienced any MS relapses in the last two years and need to be able to provide informed consent to participate. If you join this trial, you'll receive the tolDC treatment and be closely monitored for any side effects or improvements in your condition. It’s important to note that certain previous treatments or health conditions may disqualify some individuals from participating, so a thorough screening will take place.

Gender

ALL

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.