In KTE-C19 therapy, patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
Kite Pharma chairman, president and chief executive officer Arie Belldegrun said: "This is a very exciting time for Kite, and we’re grateful to the patients and clinical researchers who greatly contribute to the progress of our KTE-C19 program.
"We are at a pivotal moment for our Company and for the industry as a whole as we initiate the first company-sponsored clinical trial of CAR T-cell therapy in patients with refractory diffuse large B-cell lymphoma (DLBCL)."
The single arm, open-label, multi-center Phase I/II trial is designed to determine the safety and efficacy of KTE-C19 in patients with refractory DLBCL, primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL).
Following completion of the Phase I portion of the trial, the company intends to proceed with the Phase II portion that will include a total of 112 patients.
Belldegrun noted: "Kite has met its goal of initiating the first company-sponsored clinical trial of KTE-C19 in the first half of this year and plans to commence an additional three trials of KTE-C19 before year-end.
"Our first study is expected to provide pivotal results in 2016, leading to the potential launch and commercialization of KTE-C19 in 2017."