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Relapsing-Remitting Multiple SclerosisPhase 2TolDecCOMBINEMNCT04530318

Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis

A Phase 2 study testing Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded in people with Relapsing-Remitting Multiple Sclerosis, run by Judit Pich at 5 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this project is to assess properly the clinical efficacy of TolDec therapy by imaging, clinical and surrogate end-points related with the activity of the disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsing-Remitting Multiple Sclerosis
What is being tested?
Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
5 sitesSpain
Study dates
27 Jan 2020to 15 Mar 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18-65 years old.
  • Patients diagnosed with RRMS according to 2017 McDonald criteria.
  • MS disease duration < 10 years.
  • Expanded disability status scale (EDSS) from 0 to < 5.5.
  • Patients eligible to start or already are in on treatment with first line immunomodulatory treatment (interferon beta 1a, interferon beta 1b, glatiramer acetate, teriflunomide or dymethyl-fumarate).
  • Able to sign informed consent.
  • Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.

Who cannot join

  • Presence of a relapse or use of steroids 30 days prior to screening visit.
  • Concomitant use of any type of immunomodulatory / immunosuppressive therapy.
  • Use of previous immunosuppressive or cytotoxic therapy in the last 6 months. Use of previous alemtuzumab, cladribine or bone marrow or stem cell transplant at any time.
  • Patients unable or unwilling to undergo MRI scans.
  • Severe systemic diseases or history of cancer or hereditary familiar cancer.
  • Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease.
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  • Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access).
  • Pregnant or breastfeeding women.
  • Drug or alcohol abuse.
  • Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at screening.
  • Ongoing known bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests at screening.
  • Patients with a known history of syphilis or tuberculosis or test positive for syphilis (positive rapid plasma reagin, RPR) or tuberculosis (positive skin test) at screening. Active or latent tuberculosis (TB).
  • Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol.
  • Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study.
  • Participation in other experimental studies within the previous 90 days prior to screening visit.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Moisés Broggi

    L'Hospitalet de Llobregat, Barcelona

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

Other trials in Spain

About this study

The aim of this project is to assess properly the clinical efficacy of TolDec therapy by imaging, clinical and surrogate end-points related with the activity of the disease.

Read the detailed description

Our working hypothesis is to make a combination therapy with low-moderate efficacy immunomodulatory drugs with the aim of increasing efficacy without causing serious adverse effects such as those associated with the available high-efficacy therapies. Cellular therapies represent a highly specific treatment aimed to target selective "pathogenic" cells subsets. Tol-Dec loaded with immunogenic peptides interacts with Ag-specific T lymphocytes inducing regulatory T cells without affecting other cell subsets leading to a antinflammatory shift of immunological responses.

Being tested
Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded, Placebo
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous peripheral blood differentiated adult tolerogenic dendritic cells expandedOther

    Also called TolDec

    The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4).

  • PlaceboOther

    The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4).

Study groups in NCT04530318
Study groupRoleWhat they receive
TolDecExperimentalAutologous peripheral blood differentiated adult tolerogenic dendritic cells expanded
Receives: Other: Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded
PlaceboPlacebo comparatorPlacebo of dendritic cells
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24).

    Measured: week 12, 18 and 24

  2. Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period.

    Measured: week 24

  3. Proportion of patients with any Grade 3 -4 adverse events related to study product.

    Measured: week 24

Secondary outcomes (19)

  1. Proportion of patients with any Grade 3 -4 adverse events related to study product.

    Measured: week 24

  2. Proportion of patients with any SAE events related to study product.

    Measured: week 24

  3. Proportion of patients with at least one MS relapse during the study period.

    Measured: week 24

  4. Total number of MS relapse at 24 weeks.

    Measured: week 24

  5. Time to first MS relapse during the study period.

    Measured: week 24

  6. Changes from baseline in the disability progression by Expanded Disability Status Scale (EDSS) at week 24.

    Measured: week 24

  7. Changes from baseline in the disability progression by Multiple Sclerosis Functional Composite (MSFC) at week 24.

    Measured: week 24

  8. Changes from baseline in the number of CUA lesion at week 24.

    Measured: week 24

  9. Proportion of patients free from CUA lesion, gadolinium-enhancing lesions on T1 MRI and new or enlarged lesions on T2-MRI thought the 24 weeks of study.

    Measured: week 24

  10. Changes from baseline in the number of Gd-enhancing T1 lesions by scan (mean number of the sum at week 12, 18 and 24) and at week 24.

    Measured: week 24

  11. Changes from baseline in number of new or enlarging T2 lesions by scan (mean number of the sum at week 12, 18 and 24) and at week 24.

    Measured: week 24

  12. Changes from baseline in brain global, white and gray matter volume and cervical cord volume on MRI at 24 weeks.

    Measured: week 24

  13. Changes from baseline in the number of cortical lesions on MRI at 24 weeks.

    Measured: week 24

  14. Changes from baseline in MR measurements of diffuse damage of brain tissue by MTR at 24 weeks

    Measured: week 24

  15. Changes from baseline in MR measurements of relaxation times of T1 and T2 by MTR at 24 weeks.

    Measured: week 24

  16. Changes in DTI measures as mean diffusivity (MD), fractional anisotropy (FA), radial diffusivity (Dr) and axial diffusivity (Da) at 24 weeks.

    Measured: week 24

  17. Changes from baseline in cytokine production (including IFNgamma, IL-17, IL-4 and IL-10) in response to specific peptide stimulation in peripheral blood mononuclear cells (PBMCs) culture supernatants at 12 and 24 weeks.

    Measured: week 24

  18. Changes from baseline in T cell proliferation to immunogenic peptides at 12 and 24 weeks.

    Measured: week 24

  19. Changes from baseline in immune cell subsets in PBMCs including PBMC subtypes, T lymphocytes subpopulations and Treg subsets, CD4 and CD8 GM-CSF 'encephalitogenic' T cells and T cell subtypes by activation memory phenotype at 12 and 24 weeks.

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start27 Jan 2020
  3. Primary completion9 Sep 2025
  4. Study completion15 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530318
Sponsor's protocol ID
TolDec-COMBINEM
Other IDs
2020-000737-41
Acronym
TolDecCOMBINEM
Status last verified
Feb 2026
First submitted
25 Aug 2020
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded in people with Relapsing-Remitting Multiple Sclerosis, run by Judit Pich at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). (time frame: week 12, 18 and 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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