On November 9, 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 initiated a phase 2 clinical study of KTE-C19 (ZUMA-2) for the treatment of r/r MCL (Press release, Kite Pharma, NOV 9, 2015, View Source [SID:1234508138]). Schedule your 30 min Free 1stOncology Demo! 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. In addition to ZUMA-2, Kite recently initiated a phase 2 clinical study of KTE-C19 (ZUMA-1) in patients with refractory, aggressive non-Hodgkin’s lymphoma (NHL).
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"This phase 2 study in r/r MCL will address an unmet need in patients who have failed prior therapies," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer. "In addition to ZUMA-1 in refractory, aggressive NHL and ZUMA-2 in r/r MCL, we expect to initiate two additional pivotal KTE-C19 studies in acute lymphoblastic leukemia by the end of this year."
ZUMA-2 will proceed as a single arm, open-label, multi-center study, designed to determine the efficacy and safety of KTE-C19 in patients with MCL whose disease is refractory to or has relapsed following anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy and ibrutinib. This study plans to enroll 70 subjects. Additional details about this study will soon be posted to ClinicalTrials.gov.