On August 15, 2019 City of Hope reported that the first-in-human, phase 1 T cell trial for patients who have human papillomavirus (HPV)-associated cancers that have relapsed, or are resistant to treatment, is now open at City of Hope (Press release, City of Hope, AUG 15, 2019, View Source [SID1234538789]). The institution is the first to open such a trial on the West Coast.
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The research trial, which is sponsored by Kite, a Gilead Company, targets HPV-associated cancers with the HPV type 16, a strain which causes about 70% of all cervical cancers worldwide, as well as oropharyngeal, anal, penile and vaginal cancers.
Nearly 88,000 HPV-associated cancers will be diagnosed this year in the United States, and the American Cancer Society estimates that more than 19,500 deaths will occur due to HPV-associated cancers.
"Early stage HPV-associated cancers are quite treatable, but the story is different when the cancer returns or is resistant to treatment," said Erminia Massarelli, M.D., Ph.D., M.S., City of Hope associate clinical professor in the Department of Medical Oncology & Therapeutics Research. "These patients currently have few treatment options so we are hopeful that T cell therapy will work."
T cells play a central role in the immune system by destroying diseased cells, including tumor cells, throughout the body. For the trial, a person’s own T cells will be collected and genetically engineered in a laboratory with KITE-439, an E7 T-cell receptor. The receptor is designed to target antigens expressed in the cancer cells that are infected by HPV, potentially inducing T cell activation against the cells. Patients will receive a single dose of KITE-439.
Patients who join the trial must be HLA-A*02:01 positive, relapsed or refractory after at least one line of therapy, and meet other inclusion criteria. Patients also receive high-dose chemotherapy prior to receiving the T cells; the chemotherapy makes "space" in a person’s immune system for the genetically engineered cells to engraft and mediate an anti-cancer effect. The T cell therapy is investigational, and the trial will test if it is safe and efficacious.
"City of Hope continues to lead the way in advancing CAR T and T cell therapies across a range of blood and solid tumor cancers," said Stephen J. Forman, M.D., City of Hope’s Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation and leader of the Hematologic Malignancies and Stem Cell Transplantation Institute. "City of Hope pursues its own CAR T and T cell technology in active preclinical and clinical programs, and also works with other academic researchers and biopharmaceutical companies to make innovative therapies available to more patients."
Patients interested in more trial information can click here. The trial is part of City of Hope’s T Cell Therapeutics Research Laboratory, which currently has 20 T cell and CAR T clinical trials.