MIAMI, May 24, 2016 – Researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine are testing a novel cellular immunotherapy approach to treating patients with diffuse large B-cell lymphoma who have failed standard therapy. This investigational anti-CD19 chimeric antigen receptor T cell (CAR-T) therapy, known as KTE-C19, is being studied in a Phase II clinical trial for patients with aggressive non-Hodgkin's lymphoma. Sylvester is the first cancer center in South Florida to treat patients using this new approach.
"CAR-T cells represent a remarkable new way of harnessing the immune system and redirecting it to destroy cancer cells," said Lazaros J. Lekakis, M.D., a hematologic oncologist at Sylvester and principal investigator for the trial at the cancer center. "In this trial, Kite Pharma, the sponsor of the study, genetically engineers the patient's own T cells, an important component of the immune system, to recognize lymphoma cells and attack them in a way that mimics the way the immune system fights serious infections."
In this clinical trial, the patient's own T cells are first collected from the peripheral blood and shipped to a special manufacturing facility. There, the T cells are genetically engineered to display a novel receptor on their surface called a chimeric antigen receptor, which enables the T cells to recognize a specific protein present on lymphoma cells called CD19. The modified cells are then sent to Sylvester, where they are transfused back to the patient to target the lymphoma.
"Kite Pharma is privileged to be collaborating with Sylvester and its distinguished researchers on the development of KTE-C19," said Arie Belldegrun, M.D., FACS, Kite's Chairman, President, and Chief Executive Officer. "The successful development of next-generation cancer therapies requires the kind of world-class expertise, vision and commitment that Sylvester contributes to our program. We share their tireless commitment to the introduction of innovative cancer therapies with the potential to transform patient care."
"Our first CAR-T cell patients had an aggressive form of diffuse large B-cell lymphoma, having failed multiple lines of standard chemotherapy," said Joseph Rosenblatt, M.D., chief of the division of hematology at Sylvester. "Our patients were very brave in seeking this investigational therapy, and so far we are very encouraged by the preliminary response to the therapy."
Non-Hodgkin's lymphoma is a common form of blood cancer with a rising incidence that is diagnosed in more than 70,000 patients each year in the United States. Although many non-Hodgkin's lymphoma patients are cured using standard chemotherapy, substantial numbers of patients fail treatment and require additional options. CAR-T cell therapy provides an innovative new option for patients who have failed standard approaches.
"We are thrilled to bring novel and extremely promising trials of CAR-T cell therapies to patients in South Florida," said Krishna V. Komanduri, M.D., director of the Adult Stem Cell Transplant Program at Sylvester. "While we have known for some time that T cells from stem cell transplant donors can cure blood cancers that fail chemotherapy, the ability to induce remissions using genetically engineered T cells from patients represents a true therapeutic breakthrough."
"Sylvester is devoted to testing cutting-edge therapies that have real potential to benefit patients at our center, our region and throughout the world, "said Sylvester Director Stephen D. Nimer, M.D. "Sylvester has embarked on an aggressive program of recruiting physicians and scientists with expertise in immunology, stem cell transplantation, and immunotherapy, so we can incorporate novel cellular therapies, including genetically engineered T cells that are modified to specifically attack cancer cells into our treatments for patients with a variety of cancers."
To learn more about this trial please visit sylvester.org or http://www.clinicaltrials.gov (NCT02348216).
About Sylvester Comprehensive Cancer Center
Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System and the University of Miami Miller School of Medicine, is among the nation's leading cancer centers and South Florida's only Cancer Center of Excellence. A 2015 study by Memorial Sloan Kettering Cancer Center, published in The Journal of the American Medical Association, showed that cancer patients treated at Sylvester have a 10 percent higher chance of survival than those treated at nearly any other cancer center in the nation. With the combined strength of more than 120 cancer researchers and 130 cancer specialists, Sylvester discovers, develops and delivers more targeted therapies, providing the next generation of cancer clinical care – precision cancer medicine – to each patient. Our comprehensive diagnostics, coupled with teams of scientific and clinical experts who specialize in just one type of cancer, enable us to better understand each patient's individual cancer and develop treatments that target the cells and genes driving the cancer's growth and survival, leading to better outcomes. At Sylvester, patients have access to more treatment options and more cancer clinical trials than most hospitals in the southeastern United States. To better serve current and future patients, Sylvester has a network of conveniently located outpatient treatment facilities in Miami, Kendall, Hollywood, Plantation, Deerfield Beach and Coral Springs, with plans to open in Coral Gables in 2016. For more information, visit sylvester.org.