IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)
brief 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.
detailed description
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 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.
official title
A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With