The efforts focused on discovering new types of treatments for human diseases sometimes seemed stalled for many years before a breakthrough occurs that leads to an extended period of significant advancements. As an example, monoclonal antibodies were first discovered several decades ago and only in the past 10 years or so has the development of new antibody drugs in clinical use greatly accelerated. The role of the immune system in cancer, whether to prevent its onset or applied as a form of therapy, has been studied intensively for decades and at times, been controversial. However, recent advances marked by remarkably positive results from clinical trials signal that a renaissance period for immune cell-based therapies to treat cancer has begun. Our lab was the first to identify a relatively rare type of immune cell that we named "double-negative T-cell" or DNT. For the past 15 years, we have studied the functions of DNTs and focused on its potential use to treat cancer. In particular, our priority has been to study the potential for DNT therapy to treat acute myeloid leukemia (AML), the most common form of adult leukemia. We have generated a body of preclinical data that is nearly complete in order to make a formal submission to Health Canada to carry out a first-in-man, Phase I trial to treat AML patients with DNT therapy. In brief, we have developed a procedure (patent pending) that allows growing the large quantities of DNTs needed for therapeutic use, we have demonstrated that DNT treatment is effective in killing AML cells in mouse models, and importantly, that DNT cell do not harm normal blood nor bone marrow cells, and hence, suggests its safety for treating patients. This proposal outlines the remaining studies that can be performed within one year to complete the clinical trial application and once approved, the clinical trial will be performed at Princess Margaret Cancer Centre.