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Kite Pharma Initiates the ZUMA-3 Study to Support Registration of KTE-C19 for Relapsed or Refractory (r/r) Acute Lymphoblastic Leukemia (ALL) in Adult Subjects


Kite Pharma, Inc. (Nasdaq: KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT™) products for the treatment of cancer, today announced that it has initiated a phase 1/2 clinical study of KTE-C19 (ZUMA-3) for the treatment of adult patients with r/r ALL. 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.

"Kite has achieved an important milestone this year, with the initiation of our third company-sponsored clinical trial for our lead product candidate, KTE-C19," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer. "The breadth of our KTE-C19 registration program underscores our commitment to addressing critical unmet needs in cancer treatment. We are grateful to all the patients, caregivers, and members of the medical community who have participated in our clinical programs."

ZUMA-3 will proceed as a single-arm, open-label, multi-center study in patients with ALL whose disease is refractory to or has relapsed following standard chemotherapy or hematopoietic stem cell transplantation. The phase 1 portion of ZUMA-3 will assess the safety of KTE-C19, and the phase 2 portion will assess efficacy and safety. The study will target to enroll a total of 75 patients. Additional details about this study can be found on, using Identifier NCT: 02614066.

About Kite's ZUMA Clinical Programs

Kite is advancing three single-arm, multi-center clinical trials to support registration of KTE-C19:

ZUMA-1 is a phase 2 study in patients with refractory, aggressive non-Hodgkin's lymphoma (NHL), including refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL).
ZUMA-2 is a phase 2 study in patients with r/r mantle cell lymphoma.
ZUMA-3 is a phase 1/2 study in adult patients with r/r ALL.

Posted-In: News FDA Press Releases


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