Multiple SclerosisPhase 1MS-tolDCNCT02618902
A "negative"dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial
A Phase 1 study testing tolerogenic dendritic cells (tolDC) in people with Multiple Sclerosis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- tolerogenic dendritic cells (tolDC)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 30 May 2017to 3 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- tolerogenic dendritic cells (tolDC)
- Keywords
- patient safety, tolerogenic dendritic cells, tolDC
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolerogenic dendritic cells (tolDC)Biological
dose-escalation
| Study group | Role | What they receive |
|---|---|---|
| tolerogenic dendritic cells (tolDC) | Experimental | Each vaccine (5x106, 10x106 , or 15x106cells in 500 µL NaCl 0.9% solution supplemented with 5% human albumin) will be administered through intradermal injection at 5 sites (100 µL/site) in the subclavicular region (5-10 cm from the cervical lymph nodes). Injection sites will alternate between left and right sides. Receives: Biological: tolerogenic dendritic cells (tolDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Occurrence and severity of adverse events will be recorded)
Occurrence and severity of adverse events will be recorded
Measured: 6 months
Feasibility (Generation of GMP-grade cell product released according to QC)
Generation of GMP-grade cell product released according to QC
Measured: 6 months
Secondary outcomes (6)
Expanded disability status scale (EDSS)
The patients' disability level well be checked during every visit
Measured: 6 months
9 Hole Peg Test (9HPT)
This is a brief, standardized, quantitative test of upper extremity function
Measured: 6 months
25 Foot walk test (T25FW)
This is a quantitative mobility and leg function performance test based on a timed 25-walk.
Measured: 6 months
Symbol Digit Modalities test (SDMT)
This test quickly screens for organic cerebral dysfunction
Measured: 6 months
Number of Gd-enhancing lesions on MRI
By means of MRI Gd-enhancing lesions will be analysed
Measured: 6 months
Number of new or enlarging T2 lesions on MRI
By means of MRI new or enlarging T2 lesions will be analysed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start30 May 2017
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zwi Berneman, University Hospital, Antwerp
- Investigators
- Nathalie Cools, PhD, Principal investigator, Universiteit AntwerpenZwi Berneman, MD, PhD, Study director, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618902
- Sponsor's protocol ID
- CCRG15-001
- Acronym
- MS-tolDC
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2015
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Willekens B, Presas-Rodriguez S, Mansilla MJ, Derdelinckx J, Lee WP, Nijs G, De Laere M, Wens I, Cras P, Parizel P, Van Hecke W, Ribbens A, Billiet T, Adams G, Couttenye MM, Navarro-Barriuso J, Teniente-Serra A, Quirant-Sanchez B, Lopez-Diaz de Cerio A, Inoges S, Prosper F, Kip A, Verheij H, Gross CC, Wiendl H, Van Ham MS, Ten Brinke A, Barriocanal AM, Massuet-Vilamajo A, Hens N, Berneman Z, Martinez-Caceres E, Cools N, Ramo-Tello C; RESTORE consortium. Tolerogenic dendritic cell-based treatment for multiple sclerosis (MS): a harmonised study protocol for two phase I clinical trials comparing intradermal and intranodal cell administration. BMJ Open. 2019 Sep 9;9(9):e030309. doi: 10.1136/bmjopen-2019-030309.
PubMed 31501122
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A "negative"dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial
- ClinicalTrials.gov ID
- NCT02618902
- Acronym / sponsor ID
- MS-tolDC / CCRG15-001
- Conditions
- Multiple Sclerosis
- Keywords
- patient safety, tolerogenic dendritic cells, tolDC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tolerogenic dendritic cells (tolDC) | Experimental | Biological: tolerogenic dendritic cells (tolDC)Each vaccine (5x106, 10x106 , or 15x106cells in 500 µL NaCl 0.9% solution supplemented with 5% human albumin) will be administered through intradermal injection at 5 sites (100 µL/site) in the subclavicular region (5-10 cm from the cervical lymph nodes). Injection sites will alternate between left and right sides. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
- Neurologically stable with no evidence of relapse for at least 30 days prior to start of screening and throughout during the screening phase;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolerogenic dendritic cells (tolDC)dose-escalation | Biological | tolerogenic dendritic cells (tolDC) |
Primary outcome
Safety (Occurrence and severity of adverse events will be recorded)
Time frame: 6 months
Occurrence and severity of adverse events will be recorded
Feasibility (Generation of GMP-grade cell product released according to QC)
Time frame: 6 months
Generation of GMP-grade cell product released according to QC
6 secondary outcomes
Expanded disability status scale (EDSS)
Time frame: 6 months
9 Hole Peg Test (9HPT)
Time frame: 6 months
25 Foot walk test (T25FW)
Time frame: 6 months
Symbol Digit Modalities test (SDMT)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 31501122Willekens B, Presas-Rodriguez S, Mansilla MJ, Derdelinckx J, Lee WP, Nijs G, De Laere M, Wens I, Cras P, Parizel P, Van Hecke W, Ribbens A, Billiet T, Adams G, Couttenye MM, Navarro-Barriuso J, Teniente-Serra A, Quirant-Sanchez B, Lopez-Diaz de Cerio A, Inoges S, Prosper F, Kip A, Verheij H, Gross CC, Wiendl H, Van Ham MS, Ten Brinke A, Barriocanal AM, Massuet-Vilamajo A, Hens N, Berneman Z, Martinez-Caceres E, Cools N, Ramo-Tello C; RESTORE consortium. Tolerogenic dendritic cell-based treatment for multiple sclerosis (MS): a harmonised study protocol for two phase I clinical trials comparing intradermal and intranodal cell administration. BMJ Open. 2019 Sep 9;9(9):e030309. doi: 10.1136/bmjopen-2019-030309.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Cools, PhD principal investigator
Universiteit Antwerpen
Zwi Berneman, MD, PhD study director
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tolerogenic dendritic cells (tolDC) in people with Multiple Sclerosis, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Occurrence and severity of adverse events will be recorded) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.