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.
This is an open-label, biomarkers-driven study. Patients with rapidly progressive ALS will be assigned to the following dose regimen of IC14: • 4 mg/kg intravenously on Day 1, followed by 2 mg/kg daily x 3 days on Days 2-4. This 4-day course will be repeated on Days 8-11. Patients will be followed for 28 days after the last dose of study drug. Patients will all undergo [11C]-PBR28-MR-PET scans at Massachusetts General Hospital at two time points: before treatment onset and after the last treatment cycle. Patients will be followed for 28 days after the last dose of study drug for safety.
18 Years to 80 Years, all genders, not accepting healthy volunteers,