A first-in-human clinical trial to treat patients with multiple sclerosis by vaccination with tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practice (GMP) will be conducted. In doing so, the feasibility and safety of administering myelin-derived peptide-pulsed tolDC in patients with MS will be assessed.
A phase I dose-escalating clinical trial will be conducted in a coordinated and comprehensive manner to determine safety and tolerability, and to enable selection of a suitable dose regimen for phase II trials. The primary objective of the phase I study will be to determine whether tolDC-based therapy is safe and well tolerated and to establish the dose-response, with clinical relapse rates, neurological disability (assessed using various scales) and MRI endpoints, measured over 12 months. Patients will serve as their own controls pre- and post-vaccination. Completion of screening assessments and confirmation of eligibility criteria should take no longer than 6 weeks. First-line treatments will be stopped 6 weeks before baseline at the latest.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
dose-escalation
Antwerp University Hospital
Edegem, Belgium
Safety (Occurrence and severity of adverse events will be recorded)
Occurrence and severity of adverse events will be recorded
Time frame: 6 months
Feasibility (Generation of GMP-grade cell product released according to QC)
Generation of GMP-grade cell product released according to QC
Time frame: 6 months
Expanded disability status scale (EDSS)
The patients' disability level well be checked during every visit
Time frame: 6 months
9 Hole Peg Test (9HPT)
This is a brief, standardized, quantitative test of upper extremity function
Time frame: 6 months
25 Foot walk test (T25FW)
This is a quantitative mobility and leg function performance test based on a timed 25-walk.
Time frame: 6 months
Symbol Digit Modalities test (SDMT)
This test quickly screens for organic cerebral dysfunction
Time frame: 6 months
Number of Gd-enhancing lesions on MRI
By means of MRI Gd-enhancing lesions will be analysed
Time frame: 6 months
Number of new or enlarging T2 lesions on MRI
By means of MRI new or enlarging T2 lesions will be analysed
Time frame: 6 months
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