New Immune-Calming therapy could slow progressive MS
NCT ID NCT07020715
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase IIa trial tests a personalized cell therapy for people with progressive multiple sclerosis (MS). The treatment uses the patient's own immune cells, turned into 'tolerogenic dendritic cells' that are designed to calm the immune system and stop it from attacking the nerves. Fourteen participants will receive the therapy and be monitored for safety and disability progression over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tolerogenic dendritic cells (tolDC) made from the patient's own blood cells
- What this could lead to
- If successful, this could lead to a treatment that slows or stops disability progression in people with progressive multiple sclerosis.
- What could go wrong
- This is a very early, small trial with only 14 participants, so results may not apply to everyone. The therapy is complex and may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Germans Trias i Pujol Hospital (HUGTiP)
Badalona, 08916, Spain
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Universitair Ziekenhuis Antwerpen (UZA)
Edegem, 2650, Belgium
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Other studies related to the condition(s) this trial covers.
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- Can diet ease the crushing fatigue of multiple sclerosis?
- One-Time CAR-T infusion tested against progressive MS
- Can PET scans reveal hidden brain inflammation in MS?
- Can a pill rebuild the Brain's insulation? MS trial puts remyelination to the test
- Migraines and tension headaches may be hidden companions to multiple sclerosis