Dendritic cell therapy combined with immunomodulatory treatment for multiple sclerosis

Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis

This study is testing a new treatment that combines dendritic cell therapy with other medications to see if it can help people with relapsing-remitting multiple sclerosis feel better while reducing side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer (Academic / other)
• Drugs / interventions: alemtuzumab
• Locations: 5 sites (Hospitalet de Llobregat, Barcelona and 4 other locations)
• Trial ID: NCT04530318 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate the clinical efficacy of TolDec therapy in patients with relapsing-remitting multiple sclerosis (RRMS) by utilizing imaging, clinical assessments, and surrogate endpoints related to disease activity. The approach involves combining low to moderate efficacy immunomodulatory drugs with dendritic cell therapy to enhance treatment effectiveness while minimizing serious side effects associated with high-efficacy therapies. The therapy targets specific pathogenic cell subsets, inducing regulatory T cells to promote an anti-inflammatory immune response.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 diagnosed with RRMS for less than 10 years and with a disability status scale score of less than 5.5.

Not a fit: Patients experiencing a relapse or those currently using steroids or other immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a more effective and safer treatment option for patients with relapsing-remitting multiple sclerosis.

How similar studies have performed: While this approach is innovative, similar studies exploring dendritic cell therapies in autoimmune conditions have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age between 18-65 years old.
2. Patients diagnosed with RRMS according to 2017 McDonald criteria.
3. MS disease duration \< 10 years.
4. Expanded disability status scale (EDSS) from 0 to \< 5.5.
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).
6. Able to sign informed consent.
7. 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.

Exclusion Criteria:

1. Presence of a relapse or use of steroids 30 days prior to screening visit.
2. Concomitant use of any type of immunomodulatory / immunosuppressive therapy.
3. 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.
4. Patients unable or unwilling to undergo MRI scans.
5. Severe systemic diseases or history of cancer or hereditary familiar cancer.
6. Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease.
7. Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access).
8. Pregnant or breastfeeding women.
9. Drug or alcohol abuse.
10. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at screening.
11. 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.
12. 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).
13. Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol.
14. 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.
15. Participation in other experimental studies within the previous 90 days prior to screening visit.

Where this trial is running

Hospitalet de Llobregat, Barcelona and 4 other locations

• Hospital Moisés Broggi — Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
• Hospital Universitari de Bellvitge — Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
• Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
• Hospital de Sant Pau — Barcelona, Spain (Recruiting)
• Hospital del Mar — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Yolanda Blanco, MD

Conditions Relapsing-Remitting Multiple Sclerosis