A "negative"dendritic Cell-based Vaccine for the Treatment of Multiple

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

CompletedPhase 1MS (type not specified)NCT02618902

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • tolerogenic dendritic cells (tolDC)

What it measured

Main measures

  • Safety (Occurrence and severity of adverse events will be recorded)

    6 months

    Safety

  • Feasibility (Generation of GMP-grade cell product released according to QC)

    6 months

    Feasibility

Other measures (6)

  • Expanded disability status scale (EDSS)

    6 months

    Disability progression

  • 9 Hole Peg Test (9HPT)

    6 months

    Disability progressionArm and hand function

  • 25 Foot walk test (T25FW)

    6 months

    Disability progressionWalking and mobility

  • Symbol Digit Modalities test (SDMT)

    6 months

    Thinking and memory

  • Number of Gd-enhancing lesions on MRI

    6 months

    MRI lesions

  • Number of new or enlarging T2 lesions on MRI

    6 months

    MRI lesions

Who could take part

MS (type not specified) · 18 to 60 · EDSS 0 to 6.5

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      May 2017

    2. Main results due

      Feb 2022

    3. Finished

      Feb 2022

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