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Multiple Sclerosis, Relapsing-RemittingPhase 1/2SCLEROLYMNCT02427776

A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis

A Phase 1/2 study testing Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope in people with Multiple Sclerosis, Relapsing-Remitting, run by Imcyse SA at 3 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis. The study duration for the patients (from start of baseline to end of follow-up) is 270 days. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesBelgium
Study dates
Jan 2015to Aug 2016
Phase
Phase 1/2
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males and females 18 to 60 years of age
  • Patients closely followed up for at least one year prior to inclusion (i.e. prior to the start of the baseline phase) if the diagnosis of the disease was made more than one year ago, to ensure that all possible episodes of clinical relapses which occurred during this interval of time were recorded and documented
  • Multiple sclerosis that meets the 2010 revised McDonald criteria
  • Relapsing/remitting type of multiple sclerosis (which includes clinically isolated syndromes if imaging shows brain lesions disseminated in space and time)
  • Radiologically active disease defined by at least one gadolinium-enhancing lesion on a T1-weighted magnetic resonance imaging brain scan performed recently (i.e. within 3 months prior to inclusion)
  • Disease-modifying drug naïve patients or patients with stable and adequately taken disease-modifying therapy (interferon β-1, glatiramer acetate, or dimethyl fumarate) for at least six months before inclusion (NOTE: Other disease modifying drugs might be added at a later date, depending on the results of current investigations)
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  • EDSS Score <= 5.5
  • Positive predictive test in vitro for patient's CD4+ cell reactivity to immunogenic peptide
  • Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment and follow-up phase of the study (three pregnancy tests will be required prior to and during the study: (1) during the screening phase, (2) about one week prior to leukapheresis, and (3) about one week prior to re-infusion of autologous cells)
  • Fully informed written consent obtained

Who cannot join

  • Positive only for the HLA DRB1*0101, DRB1*0102, DRB1*0401, DRB1*0426 alleles or for the combination of the previous alleles.
  • Evidence of clinical relapse and use of intravenous or oral corticosteroids within 30 days prior to inclusion
  • Therapeutic escalation anticipated (including change of disease modifying drug), other than the cell-based immunotherapy of this study, within the next six months
  • Significant coexisting systemic disease including renal insufficiency
  • Positive serology for hepatitis B and C, AIDS and syphilis
  • Participation in another interventional clinical study, currently or during the past three months

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • University Hospital Leuven (Gasthuisberg)

    Leuven, 3000

  • University Hospital of Liège

    Liège, 4000

Other trials in Belgium

About this study

Official title: A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL)

The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis.

The study duration for the patients (from start of baseline to end of follow-up) is 270 days.

Being tested
Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitopeBiological

    1 administration comprising 5 - 50 millions of cells

Study groups in NCT02427776
Study groupRoleWhat they receive
IMPExperimentalNot described
Receives: Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of the cell based immunotherapy (Adverse events)

    Adverse events

    Measured: 6 months

  2. Safety of the cell based immunotherapy (Vital signs)

    Vital signs

    Measured: 6 hours

  3. Safety of the cell based immunotherapy (Physical examination)

    Physical examination

    Measured: 6 months

  4. Safety of the cell based immunotherapy (Laboratory parameters)

    Laboratory parameters

    Measured: 6 months

  5. Safety of the cell based immunotherapy (MRI)

    MRI

    Measured: 6 months

Secondary outcomes (5)

  1. MRI derived parameters

    • Cumulative number and mean number per scan of active inflammatory lesions
    • Cumulative number and mean number per scan of new lesions
    • Cumulative number and mean number per scan of enlarged lesions

    Measured: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

  2. Expanded Disability Status Scale (EDSS)

    Measured: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

  3. Clinical relapses

    Measured: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

  4. Circulating MOG specific cytolytic CD4+ cells

    Measured: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

  5. Circulating anti-MOG antibodies

    Measured: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: study ended prior enrollment of the first patient because of unexpected issues in the manufacturing process prevented production of adequate clinical batches

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02427776
Sponsor's protocol ID
MS/MOGMOD/CT/FIH/01
Acronym
SCLEROLYM
Status last verified
Aug 2017
First submitted
2 Apr 2015
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope in people with Multiple Sclerosis, Relapsing-Remitting, run by Imcyse SA at 3 sites 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: study ended prior enrollment of the first patient because of unexpected issues in the manufacturing process prevented production of adequate clinical batches). Results are not available in the source record.

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 of the cell based immunotherapy (Adverse events) (time frame: 6 months). The study lists 5 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 NCT02427776.

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 22 Aug 2017.

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