NCT07020715Not yet recruitingPhase 2
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Aug 2026
Brief summary (registry, in English)
To assess the safety and efficacy of administering myelin-derived peptide-pulsed tolDC, manufactured under Good Manufacturing Practice (GMP) conditions, in patients with progressive forms of MS, within a phase IIa clinical trial framework. - To evaluate the safety of administering tolDC, the occurrence and severity of adverse events will be recorded. - To evaluate the efficacy of tolDC administration, the change in Expanded Disability Severity Scale (EDSS) will be assessed.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 2 Mar 2026
- Lead sponsor
- Universitair Ziekenhuis Antwerpen
- Diseases
- Multiple sclerosis
- NCT number
- NCT07020715
- EU CT number
- 2025-522040-40-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 14
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Drug or alcohol abuse
- Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease that could impact safety or outcome measures.
Other illness
- Active or chronic infection with hepatitis B, C, HIV, syphilis or tuberculosis
- Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.
- History of or actual signs of immunodeficiency or malignancies (with the exception of treated basal cell carcinoma)
Lab values
- 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
Other
- Splenectomy
- Pregnancy or planning pregnancy in the next 12 months and breast feeding
- Inability to undergo MRI assessments
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.