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Clinical Trials

Date: 2015-11-09

Type of information: Initiation of the trial

phase: 2

Announcement: initiation of the trial

Company: Kite Pharma (USA - CA)

Product: axicabtagene ciloleucel (KTE-C19) (autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor)

Action mechanism: cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector 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.

Disease: relapsed/refractory mantle cell lymphoma

Therapeutic area: Cancer - Oncology - Rare diseases

Country: USA

Trial details:

  • ZUMA-2 (Study KTE-C19-102) is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with relapsed/refractory mantle cell lymphoma. (NCT02601313)

Latest news:

  • • On November 9, 2015, Kite Pharma announced that it has initiated a phase 2 clinical study of KTE-C19 (ZUMA-2) for the treatment of r/r MCL. 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. 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). The company also expects to initiate two additional pivotal KTE-C19 studies in acute lymphoblastic leukemia by the end of this year.

Is general: Yes