NCT02903537

Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)

Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Fundació Institut Germans Trias i Pujol · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of the intranodal administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most appropriate regime for the development of future therapeutic trials. To evaluate the preliminary proof of concept by clinical and/or radiological activity and immunological markers.

Detailed description

Phase I dose ascending ("best of five") clinical trial. First group will start by intranodal injection in cervical lymph nodes of 5\*10\^6 tolDC-VitD3. Up titration depending on security outcomes to 10\*10\^6 tolDC-VitD3, same route in second cohort dose and next uptitration to 15\*10\^6 tolDC-VitD3. Six cycles per patient with the following schema: for the first four cycles the administration will be each 2 weeks, for the remaining 2 cycles administration each 4 weeks. A last cohort with the dose identified in the previous groups, administered in patients treated with beta interferon, same route, same dose schema.

Conditions

• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Chronic Progressive

Interventions

Type	Name	Description
DRUG	Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3)	Intranodal administration
DRUG	Interferon-beta	Subcutaneous administration interferon-beta

Timeline

• Start date: 2017-07-06
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2016-09-16
• Last updated: 2023-07-07

Locations

2 sites across 1 country: Spain