Kite Pharma Initiates Phase 2 Clinical Study of KTE-C19 (ZUMA-2) in Patients With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) to Support Registration for a Second Indication

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!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free 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).

"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.