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Kite Pharma (KITE) Initiates ZUMA-3 study for KTE-C19 in Relapsed or Refractory (r/r) Acute Lymphoblastic Leukemia (ALL) in Adult Subjects

December 2, 2015 9:32am

KITE "walks the talk" at ASH having closed at $76.05 and is UP +$0.60 in the pre-market

KITE has initiated a P1/2 clinical study of KTE-C19 (ZUMA-3) for the treatment of adult patients with r/r ALL.

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 Bottom Line: The P1 of ZUMA-3 assessed the safety of KTE-C19, and the P2 portion will assess efficacy and safety. The study will target to enroll a total of 75 patients.

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. A 3rd company-sponsored clinical trial for its lead product candidate, KTE-C19

Multiple shots on goal:

Kite is advancing three (3) single-arm, multi-center clinical trials to support registration of KTE-C19:

ZUMA-1 is a P2 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 P2 study in patients with r/r mantle cell lymphoma;

ZUMA-3 is a P1/2 study in adult patients with r/r ALL.

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