The trial includes an investigational therapy for patients with refractory aggressive non-Hodgkin’s lymphoma (NHL).
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
"We are enthusiastic about the possibility that KTE-C19 can safely put patients with chemotherapy-refractory aggressive lymphoma into remission," said Frederick L. Locke, M.D., medical oncologist, and trial investigator, in the Department of Blood & Marrow Transplantation at Moffitt. "Kite has done an outstanding job advancing immunotherapy for testing in a multi-institution trial."
Trial sponsor, Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous T-cell therapy (eACTTM) designed to restore the immune system’s ability to recognize and eradicate tumors.
"This is a very exciting time for Kite, and we’re grateful to the patients and clinical researchers who greatly contribute to the progress of our KTE-C19 program," said Kite President, Chairman and CEO, Arie Belldegrun, M.D., FACS.
Kite’s Phase 1/2 clinical trial of KTE-C19 is a single-arm, open-label, multicenter study designed to determine the safety and efficacy of KTE-C19 in patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) or transformed follicular lymphoma (TFL).
Upon completion of the Phase 1 portion of the study, Moffitt anticipates participating in Kite’s expected Phase 2 portion, which will include approximately 112 patients across multiple clinical trial sites.