ANCHOR Cells for the Treatment of Patients with Relapsed or Refractory CD19-Positive B-Cell Lymphoma or Leukemia, ANCHOR Study
This phase I clinical trial studies the best dose and side effects of allogeneic natural killer T-cells expressing CD19-specific chimeric antigen receptor and interleukin-15 (ANCHOR cells) in treating patients with CD19-positive lymphoma or leukemia that have come back (relapsed) or do not respond to treatment (refractory). This trial combines two different ways of fighting disease, antibodies, and immune cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. Immune cells, also called lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and lymphocytes have been used to treat patients with cancer. The antibody used in this study is called anti-CD19. It sticks to leukemia cells because of a substance on the outside of these cells called CD19. For this clinical trial, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the NKT cells, a special type of lymphocytes that can kill tumor cells but not very effectively on their own. When an antibody is joined to a T cell in this way, it is called a chimeric receptor. In the laboratory, it has also been found that NKT cells work better if proteins that stimulate lymphocytes are added, such as one called CD28. Adding the CD28 makes the cells last for a longer time in the body but may be not long enough for them to be able to kill the leukemia cells. Adding an extra stimulating protein, called IL-15, may allow the cells an even better chance of killing the leukemia cells. This trial evaluates whether putting the anti-CD19 chimeric receptor with CD28 and the IL-15 into NKT cells grown from a healthy individual may be more effective in treating patients with relapsed or refractory CD19-positive lymphoma or leukemia.