Date: 2017-08-02
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
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/CAR-T cell therapy. Axicabtagene ciloleucel (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. Axicabtagene ciloleucel (KTE-C19) received Breakthrough Therapy Designation (BTD) by the FDA in December 2015 .
Disease: relapsed/refractory indolent B-cell non-Hodgkin lymphoma
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- ZUMA-5 is a single-arm, open-label, multi-center study in patients with iNHL whose disease has relapsed within two years of first line treatment, is refractory to second line or greater therapy or has relapsed at any point after transplant. The study will enroll approximately 50 patients. (NCT03105336)
Latest
news:
- • On August 2, 2017, Kite Pharma announced that patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma ( iNHL) are now being treated in its Phase 2 ZUMA-5 trial with axicabtagene ciloleucel (axi-cel). This study builds upon early clinical results using the same axi-cel anti-CD19 construct previously published in the March 2012 issue of Blood, "B-cell Depletion and Remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells," in which patients with relapsed/refractory iNHL experienced a high response rate and durable disease remissions in a clinical trial at the National Cancer Institute (NCI).
- B-cell iNHL is expected to account for approximately 25 percent of 2017 newly diagnosed NHL cases in the United States (U.S.). Follicular lymphoma is the most common type of iNHL and one of the most common subtypes of NHL. The company estimates that there will be approximately 4,700 patients in 2017 with follicular lymphoma in the U.S. who could potentially benefit from CAR-T therapy.
Is
general: Yes
