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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.
EU CTIS ID: 2025-522040-40-01
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Previous treatment with alemtuzumab, autologous hematopoietic stem cell transplantation or cladribine in the past 3 years.
- 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.
- 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
See the full eligibility 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
- Previous treatment with alemtuzumab, autologous hematopoietic stem cell transplantation or cladribine in the past 3 years.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.