SANTA MONICA, CA, USA I December 7, 2015 I Kite Pharma, Inc. (KITE) today announced that it has initiated a phase 1/2 clinical study of KTE-C19 (ZUMA-4) for the treatment of pediatric and young 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.
“With the commencement of ZUMA-4, Kite has achieved its goal of initiating four company-sponsored trials this year for its lead product candidate, KTE-C19,” said David Chang, M.D., Ph.D., Kite’s Executive Vice President, Research and Development, and Chief Medical Officer. “Our ZUMA trials are investigating critical needs in non-Hodgkin lymphoma (NHL) and ALL in patients with advanced, relapsed or refractory disease who have few or no other treatment options.”
“We are enthusiastic about the possibility that KTE-C19 could safely put children and young adults who have persistent ALL despite multiple prior standard therapies into complete remissions,” said internationally recognized leukemia expert Leonard S. Sender, M.D., Medical Director and Division Chief, and ZUMA-4 trial investigator, at Children’s Hospital of Orange Country. “Kite has done an outstanding job advancing immunotherapy for testing in multiple multi-center trials, and we are thrilled to offer this trial to our young patients and their families.”
ZUMA-4 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-4 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 will be available on ClinicalTrials.gov.
About Kite’s ZUMA Clinical Programs
| Study | Phase | Indication | Status |
| ZUMA-1 NCT02348216 |
Phase 2 Pivotal (N=112) |
Refractory DLBCL, PMBCL, TFL | Phase 2 enrolling |
| ZUMA-2 NCT02601313 |
Phase 2 Pivotal (N=70) |
Relapsed/refractory MCL | Phase 2 enrolling |
| ZUMA-3 NCT02614066 |
Phase 1/2 Pivotal (N=75) |
Relapsed/refractory Adult ALL | Phase 1/2 enrolling |
| ZUMA-4 | 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
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT(TM)) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
SOURCE: Kite Pharma
