On November 2, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported that it has opened enrollment for the Phase 2 portion of its ongoing Phase 1/2 clinical trial (ZUMA-1) of KTE-C19 in patients with refractory, aggressive NHL (Press release, Kite Pharma, NOV 2, 2015, View Source [SID:1234507879]). KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Schedule your 30 min Free 1stOncology Demo! "Kite has achieved a pivotal milestone with the initiation of our Phase 2 KTE-C19 multi-center clinical trial in DLBCL. We are deeply grateful to the patients and clinical researchers who have participated in our program. We look forward to presenting top-line data from the Phase 1 portion of the trial at ASH (Free ASH Whitepaper) and anticipate reporting interim results from the study next year," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer.
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Dr. Belldegrun continued, "With inputs from regulatory agencies, we designed ZUMA-1 to enable market registration of KTE-C19 for refractory, aggressive NHL. Based on our progress and current timelines, Kite remains on track towards potential launch and commercialization of KTE-C19 in 2017."
Kite’s ZUMA-1 trial of KTE-C19 is a single arm, open-label, multi-center 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). Kite expects that the Phase 2 portion of the trial will include a total of approximately 112 patients. Additional information about Kite’s Phase 1/2 study may be found at ClinicalTrials.gov, using Identifier NCT: 02348216.