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Interim Efficacy Results and BLA Filing Expected in 2016
The DLBCL cohort of ZUMA-1 enrolled patients whose disease is chemorefractory (no response to last line of therapy or has relapsed within 12 month of autologous stem cell therapy). Patients received a lymphodepletion regimen that consisted of "low-dose" chemotherapy regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) daily for 3 days prior to infusion of the target KTE-C19 dose of 2 x 106 cells/kg.
"We are excited to complete enrollment in our first multi-center KTE-C19
study, an important milestone toward bringing this potential
breakthrough therapy to patients with an urgent need for better
treatment," said
About Kite's ZUMA Clinical Programs for KTE-C19
KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
Study | Phase | Indication | Status |
ZUMA-1NCT02348216 |
Phase 2 Pivotal
(N=112) |
Chemorefractory DLBCL (N=72)
PMBCL, TFL (N=40) |
Phase 2 enrollment complete
Phase 2 enrolling |
ZUMA-2NCT02601313 | Phase 2 Pivotal(N=70) | Relapsed/refractory MCL | Phase 2 enrolling |
ZUMA-3NCT02614066 | Phase 1/2 Pivotal(N=75) | Relapsed/refractory Adult ALL | Phase 1/2 enrolling |
ZUMA-4 NCT02625480 | Phase 1/2 Pivotal(N=75) | Relapsed/refractory Pediatric ALL | Phase 1/2 enrolling |
DLBCL = diffuse large B-cell lymphoma | |||
PMBCL = primary mediastinal B-cell lymphoma | |||
TFL = transformed follicular lymphoma | |||
MCL = mantle cell lymphoma | |||
ALL = acute lymphoblastic leukemia |
About Kite Pharma
Forward-Looking Statements
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the ability and timing of obtaining
interim KTE-C19 data and submitting a BLA with the
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