A "Negative"Dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 24 May 2021
• Main ID: NCT02618902
• Date of registration: 18/11/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Antwerp
• Public title: A "Negative"Dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial MS-tolDC
• Scientific title: A "Negative"Dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial
• Date of first enrolment: May 30, 2017
• Target sample size: 9
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02618902
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Nathalie Cools, PhD
• Affiliation: Universiteit Antwerpen

• Name: Zwi Berneman, MD, PhD
• Affiliation: University Hospital, Antwerp

Key inclusion & exclusion criteria

Inclusion Criteria:

- MS according to 2010 revised McDonald criteria (76);

- Expanded disability status scale (EDSS) of 0-6.5 inclusive;

- Disease duration of maximum 15 years and first signs or symptoms at least 6 months
prior to enrolment in the study;

- Active MS (relapsing and progressive): -1 relapse in the past year and/or

- at least 1 enhancing lesion on brain MRI in the past year

- new or enlarging T2 lesion(s) in comparison with a reference scan from maximum 1
year before

- Neurologically stable with no evidence of relapse for at least 30 days prior to start
of screening and throughout during the screening phase;

- Positive T cell reactivity response to a mix of 7 myelin-derived peptides;

- Able to sign informed consent;

- Ability to comply with the protocol assessments;

- Appropriate venous access.

- Use of adequate contraceptive measures

Exclusion Criteria:

- Previous use of immunosuppressive or cytostatic treatment, including mitoxantrone,
alemtuzumab or bone marrow transplantation or stem cell transplantation at any time
prior to enrolment;

- Treatment with fingolimod or natalizumab or dimethylfumarate or teriflunomide within
the last 3 months prior to study enrolment;

- Pregnancy or planning pregnancy in the next 12 months and breast feeding;

- Drug or alcohol abuse;

- Inability to undergo MRI assessments;

- History of or actual signs of immunodeficiency or malignancies;

- Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal
or other major disease;

- Hepatitis B, C, HIV, Syphilis or tuberculosis

- Splenectomy;

- Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity
that could interfere with the compliance to the protocol.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: tolerogenic dendritic cells (tolDC)

Primary Outcome(s)

Feasibility (Generation of GMP-grade cell product released according to QC) [Time Frame: 6 months]

Safety (Occurrence and severity of adverse events will be recorded) [Time Frame: 6 months]

Secondary Outcome(s)

Symbol Digit Modalities test (SDMT) [Time Frame: 6 months]

25 Foot walk test (T25FW) [Time Frame: 6 months]

9 Hole Peg Test (9HPT) [Time Frame: 6 months]

Number of Gd-enhancing lesions on MRI [Time Frame: 6 months]

Number of new or enlarging T2 lesions on MRI [Time Frame: 6 months]

Expanded disability status scale (EDSS) [Time Frame: 6 months]

Secondary ID(s)

CCRG15-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors