Full TitleA Phase 1/2, Open Label, Dose Escalation Study of Intravenous Administration of Single Agent NEOD001 in Subjects with Light Chain (AL) Amyloidosis Back to top
Amyloidosis is a disorder in which abnormal, misfolded proteins build up in tissues and organs, preventing them from working properly. Clumps of the abnormal proteins are called amyloid deposits. In patients with light chain amyloidosis, abnormal plasma cells produce a type of protein called an “immunoglobulin light-chain protein.” Amyloidosis may be treated with chemotherapy, but the disease often returns.
The purpose of this study is to find the highest dose of an investigational drug called NEOD001 that can be given safely in patients with light chain amyloidosis, and to observe its preliminary effectiveness as a treatment for the organ problems that are the result of light chain amyloidosis. NEOD001 is an antibody that targets a protein believed to be involved in light chain amyloidosis. It is given intravenously (by vein).Back to top
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have light chain amyloidosis and have had at least one prior regimen of therapy (stem cell transplantation is allowed) before entering the study.
- Patients should have had at least a partial response to prior treatment and not need additional active treatment, but still have organ dysfunction.
- Patients must have recovered from the serious side effects of prior treatment.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 18 and older.