IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)
Stopped: No enrollment
Australia0Started 2019-09-01
Plain-language summary
Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This 4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at two time points: before treatment onset and after the last treatment cycle. This scan will measure areas of ALS disease activity and assess response to IC14 treatment. MR-PET scans will be compared to historical controls.
Who can participate
Age range18 Years β 80 Years
SexALL
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Inclusion criteria
β. Capable of providing informed consent and informed consent form signed prior to initiation of any study-specific procedures.
β. Familial or sporadic ALS defined as clinically possible, probable, or definite by El Escorial Criteria.
β. Rapidly progressive ALS defined by the Revised ALS Functional Rating Scale (ALSFRS-R) slope β₯1 (48 minus ALSFRS-R score at screening / disease duration in months β₯ 1).
β. Upper Motor Neuron Burden Score of β₯ 25 (out of 45) at screening
β. First symptoms of ALS within 3 years of the screening visit
β. Age between 18 and 80 years at the time of the screening visit.
β. Not taking riluzole or edaravone or on a stable dose of riluzole or edaravone for at least 3 months prior to screening visit.
β. Adequate bone marrow reserve, renal and liver function:
Exclusion criteria
β. Dependence on invasive or non-invasive ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening; or presence of diaphragm pacing system at screening.
β. Exposure to any experimental treatment for ALS within the last 30 days or five half-lives, whichever is longer.
β. Treatment within 12 months with immunomodulator or immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine, interferon-Ξ±, interferon-Ξ²-1a, rituximab, alemtuzumab, azathioprine, etanercept, infliximab, adalimumab, certolizumab, golimumab, anakinra, rilonacept, secukinumab, tocilizumab, mycophenolate mofetil, methotrexate, cell-depleting agents, total lymphoid irradiation, dimethyl fumarate). Treatment with intravenous immunoglobulin (IVIG) within 2 months. Non-steroidal anti-inflammatory drugs (NSAIDs) are acceptable.
β. Exposure at any time to any cell or gene therapies under investigation for the treatment of ALS.
β. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks.
β. Live-attenuated vaccines within 30 days before dosing. Subjects must agree to forego live-attenuated vaccines throughout the study, including 60 days after the last dose of study drug.
β. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
β. History of one or more of the following: cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), uncontrolled cardiac arrhythmias, unstable ischemic heart disease, or uncontrolled hypertension (systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 110 mmHg).