Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis

NCT04530318 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: TolDec-COMBINEM2020-000737-41
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

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

  week 12, 18 and 24

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

  week 24

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

  week 24

Secondary Outcomes (19)

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

  week 24

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

  week 24

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

  week 24

• Total number of MS relapse at 24 weeks.

  week 24

• Time to first MS relapse during the study period.

  week 24

Study Arms (2)

TolDec

EXPERIMENTAL

Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded

Other: Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded

Placebo

PLACEBO COMPARATOR

Placebo of dendritic cells

Other: Placebo

Interventions

Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded OTHER

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

Also known as: TolDec

TolDec

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Judit Pich: lead

Study Sites (5)

Hospital Moisés Broggi

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yolanda Blanco, MD

  Hospital Clinic of Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager. CTU Clinic

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: January 27, 2020
• Primary Completion: September 9, 2025
• Study Completion: March 15, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)