Clinical Trials

Date: 2016-10-06

Type of information: Recruitment of the first patient

phase: 1-2a

Announcement: recruitment of the first patient

Company: Kite Pharma (USA - CA) Genentech, a member of Roche Group (USA - CA - Switzerland)

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

Action mechanism:

• cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy/immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. 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.
• Atezolizumab is a monoclonal antibody designed to target and bind to a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells.  PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells.
• PD-L1 expression in DLBCL is associated with high-risk disease and poor outcomes. The interaction of PD-L1 and PD-1, which is expressed on KTE-C19, may dampen T-cell activity in some patients. As a result, use of the two compounds in combination could provide a synergistic effect since inhibiting PD-L1 with atezolizumab may enhance and prolong the activity and proliferation of KTE-C19.
• Kite entered a clinical collaboration in March 2016 with Genentech , a member of the Roche Group, to evaluate the safety and efficacy of KTE-C19 in combination with atezolizumab.

Disease: refractory diffuse large B cell lymphoma (DLBCL)

Therapeutic area: Cancer - Oncology

Country: USA

Trial details: ZUMA-6 is the first industry-sponsored clinical trial to enroll patients to study the combination of an anti-CD19 engineered chimeric antigen receptor (CAR) T-cell and a checkpoint inhibitor. The study will proceed as a single-arm, open-label, multi-center study in patients with chemotherapy-refractory DLBCL. The Phase 1b portion of ZUMA-6 will assess the safety of KTE-C19 and atezolizumab given in sequence. The primary objective of the Phase 2 portion is to evaluate the combination's safety and efficacy. The trial will be separated into two distinct phases designated as phase 1 and phase 2. (NCT02926833)

Latest news: • On October 6, 2016, Kite Pharma announced the first patient was enrolled in ZUMA-6, a Phase 1b/2 clinical study of KTE-C19 in combination with atezolizumab, Genentech's anti-PD-L1 cancer immunotherapy. The trial is designed to evaluate the safety and efficacy of the combination in patients with refractory diffuse large B-cell lymphoma (DLBCL). The first ZUMA-6 patient was enrolled at the end of September 2016 . The results will be used to evaluate options for further development of the combination.  

Is general: Yes