Date: 2016-12-05
Type of
information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the American Society of Hematology (ASH) Annual Meeting
Company: Kite Pharma (USA - CA)
Product: axicabtagene ciloleucel (KTE-C19 (autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor)
Action
mechanism: cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy/immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
Disease: acute lymphoblastic leukemia (ALL)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details: ZUMA-4 is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.(NCT02625480)
Latest
news:
- • On December 5, 2016, Kite Pharma announced that 82 percent of patients (9 out of 11) achieved complete remission or complete remission with incomplete or partial hematological recovery in a preliminary analysis of the Phase 1 ZUMA-3 and ZUMA-4 trials of KTE-C19 in adult and pediatric relapsed/refractory acute lymphoblastic leukemia (r/r ALL). In these patients, 100 percent of responders tested negative for minimal residual disease (MRD), which has been shown to correlate with risk of disease relapse in ALL. The data were presented at the American Society of Hematology (ASH) Annual Meeting in San Diego.
In the Phase 1 trials, 13 patients were treated with KTE-C19. Eleven patients were evaluable for response and two patients have not reached the evaluation time point at the data cutoff. Patients received a low-dose conditioning chemotherapy regimen based on extensive clinical experience at the National Cancer Institute (NCI).
Five of 13 (38 percent) patients had ? grade 3 cytokine release syndrome (CRS) and five of 13 (38 percent) had ? grade 3 neurological events. One patient in ZUMA-3 died from KTE-C19 related CRS and one patient in ZUMA-4 died from a disseminated fungal infection unrelated to KTE-C19. No cerebral edema has been observed.
KTE-C19 was successfully manufactured in these 13 patients across a range of absolute lymphocyte and blast counts in a centralized and streamlined process of six to eight days.
- • On December 7, 2015, Kite Pharma 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 relapsed/refractory acute lymphoblastic leukemia (ALL). 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.
Is
general: Yes
