This phase 1 clinical trial will test the safety and effectiveness of AMV564 in treating relapsed or refractory (unresponsive to treatment) acute myeloid leukemia (AML). The primary outcome will be measured by adverse (negative) side effects and remission rate. The study is being conducted in Saint Louis, Missouri, New York City, and Houston, Texas.
The details
AMV564 is an investigational immunotherapy that uses the body’s own immune system to identify and kill AML cells. It is an antibody (protein in the immune system) that binds to a protein typically found on AML cells, which allows for a more cancer-specific targeting of the therapy. Antibody binding alerts other parts of the immune system to attack the cancer. Other studies have shown that AMV564 is effective in clearing cancer cells.
The study will examine serious adverse side effects (due to a dose increase) and remission rate for 36 months.
Who are they looking for?
This trial is recruiting 50 patients with relapsed or refractory AML. Patients should not have central nervous system involvement with AML. Participants should not have any significant kidney, liver, lung, gastrointestinal or neurological conditions. Participants cannot have received prior allogeneic stem cell or solid organ transplantation. Ideal candidates should not receive anti-cancer treatment within 14 days of entry. Those with a history of prior significant malignancy should be disease free for 3 years.
How will it work
In the first phase, 32 patients will receive increasing doses of AMV564, which will be delivered intravenously (through IV into a vein). In the second phase, 18 patients will receive AMV564 at the dose determined in the first phase.
