Table 2.
Clinical trials using tolDCs treatment in MS patients
| Type of tolDCs | NCT number | Purpose | Number of patients | Phase | Status | Antigen | Dose | Number, route, and frequency of administrations | Observations | Ref |
|---|---|---|---|---|---|---|---|---|---|---|
| Dexamethasone | NCT02283671 TolDec-EM-NMO |
—Evaluation of safety and tolerability of dexa-tolDCs treatment —Analysis of changes in the immunological profile |
8 MS patients and 4 NMO patients | I | Completed (2019) | Pool of 7 myelin peptidesa of MS + AQP463-76 for NMO | Dose-escalation study with a total of 50, 150 and 300 × 106 Dexa-tolDCs | A total of 3 i.v. doses every 2 weeks (week 0, 2, and 4) | Administration of fresh antigen-specific tolDCs The treatment was safe and well tolerated Increase secretion of IL-10 after myelin peptides stimulation at week 12 vs baseline Decrease of memory CD8 + T cells and NK cells by week 12 vs baseline | 74 |
| Autologous VitD3-tolDCs | NCT02903537 TOLERVIT-MS: Tolerance-Induction with Dendritic Cells Treated with Vitamin-D3 and Loaded with Myelin Peptides, in Multiple Sclerosis Patients |
—To determine the safety and tolerability of the intranodal administration of autologous tolDCs-VitD3 pulsed with myelin peptides 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 —To test the effect of the selected VitD3-tolDCs doses combined with IFN-β (n = 3) |
12active MS patients | I | Recruiting | Pool of 7 myelin peptidesa | Dose-escalation study using 5, 10, and 15 × 106 VitD3-tolDCs/injection Additional cohort: the highest dose of VitD3-tolDCs well-tolerated + IFN-β treatment | A total of 6 intranodal doses (cervical lymph nodes): the first 4 administrations every 2 weeks + the last 2 administrations every 4 weeks (week 0, 2, 4, 6, 10, and 14) | Administration of cryopreserved antigen-specific tolDCs | On going |
| NCT02618902 MS-tolDCs: A “Negative” Dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial |
—To determine the safety and tolerability of the intranodal administration of autologous tolDCs-VitD3 pulsed with myelin peptides 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 |
9 active MS patients | I | Recruiting | Pool of 7 myelin peptidesa | Dose-escalation study using 5, 10, and 15 × 106 VitD3-tolDCs/injection | A total of 6 intradermal doses (in the subclavicular region): the first 4 administrations every 2 weeks + the last 2 administrations every 4 weeks (week 0, 2, 4, 6, 10, and 14) | Administration of cryopreserved antigen-specific tolDCs | On going |