A first-in-human Phase I study of myeloma patients combined expanded cord blood-derived natural killer cells with stem cell transplant and high-dose chemotherapy with little or none of the side effects seen with current treatments. Natural killer (NK) cells are white blood cells that roam through the blood stream, attacking infections and potentially cancer-causing cells. The technology to grow NK cells from umbilical cord blood was developed by Nina Shah, M.D., assistant professor and Elizabeth J. Shpall, M.D., professor in the department of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center.
“Multiple myeloma is an incurable disease thought to be characterized by immune dysregulation and exhaustion, whereby proliferation of malignant plasma cells is not checked by the immune system,” said Shah. “Long-term remissions in some patients after stem cell transplants from donors have been observed, but treatment-related toxicity limits the widespread use of this therapy.” “Successful natural killer cell expansion to target dose was achieved in all the patients,” said Shah. “The cell therapy infusion resulted in no toxicity and no occurrences of graft-versus-host disease.”
Graft-versus-host disease is a condition in which the patient’s immune system is attacked by the donor stem cells. The disease can occur in patients who have received donor stem cells or immune. Twelve patients were enrolled in the study and were divided into four separate groups, with each receiving different dose levels of cord blood-derived natural killer cells. Ten of the 12 patients demonstrated high-risk disease or relapse in disease prior to study participation. Current Clinical Trials There are currently three clinical trials at MD Andersen using NK cells. Cord Blood Natural Killer Cells for Myeloma The goal of this clinical research study, which is enrolling approximately 18 patients, is to find the highest tolerable dose of immune cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell transplant to patients with myeloma. Researchers want to learn if adding NK cells will help make the stem cell transplant more effective in treating the disease. The safety of this treatment will also be studied. NK cells may kill myeloma cells that remain in your body after your last chemotherapy treatment. Treatments used in this trial are: allo (donor) stem cell transplant Allogeneic Transplant, Filgrastim, Interleukin-2, lenalidomide, and melphalan. For more information on this trial, click the SparkCures button here: Cord Blood Natural Killer Cells for Myeloma Natural Killer (NK) Cells in Cord Blood Transplantation The goal of this clinical research study, which is enrolling approximately 13 patients, is to learn if giving cells called natural killer (NK) cells after receiving fludarabine, melphalan, lenalidomide, and a umbilical cord blood (UCB) transplant can improve response in patients with leukemia, lymphoma, or myeloma. The safety of this treatment and whether NK cells can lessen the risk of graft vs. host disease (GVHD) will also be studied. Patients with a disease that is CD20-positive will also receive rituximab on this study. The first three patients enrolled on this study will not receive NK cells but will receive a UCB transplant. Umbilical Cord B and NK cells may be able to kill leukemia, lymphoma, or myeloma cells that remain in your body after chemotherapy treatment. The UCB cells are also designed to increase blood production and strengthen your immune system. Treatments used in this trial are: allo (donor) stem cell transplant, Fludarabine, lenalidomide, melphalan, , mycophenolate mofetil, rituximab, tacrolimus For more information on this trial, click the SparkCures button here: Natural Killer (NK) Cells in Cord Blood Transplantation Personalized Natural Killer (NK) Cell Therapy in Cord Blood Transplantation (CBT) The goal of this clinical research study, which is enrolling approximately 100 patients, is to learn if giving cells called natural killer (NK) cells after receiving 1 of 3 pre-treatment plans and an umbilical cord blood (UCB) transplant can improve response in participants with MDS, leukemia, lymphoma, or myeloma. The safety of this treatment and whether NK cells can lessen the risk of graft versus host disease (GVHD) will also be studied. If the disease is cluster of differentiation antigen 20 (CD20) positive, participants will also receive rituximab on this study in addition to what is described above. NK cells may kill cancer cells that remain in participant's body after their last chemotherapy treatment. The NK cells will be separated from umbilical cord blood. The device used in the laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to participant by vein. Treatments used in this trial are allo (donor) stem cell transplant, busulfan, clofarabine, cyclophosphamide, fludarabine, melphalan, mesna, radiation, rituximab, and thymoglobulin. To learn more about this trial, click on the SparkCures clinical trial finder here: Personalized Natural Killer (NK) Cell Therapy in Cord Blood Transplantation (CBT)
about the author
Lizzy Smith was diagnosed with myeloma in 2012 at age 44. Within days, she left her job, ended her marriage, moved, and entered treatment. "To the extent I'm able, I want to prove that despite life's biggest challenges, it is possible to survive and come out stronger than ever," she says.