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Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment. [8] T cells are removed from a person with lymphoma and genetically engineered to produce a specific T-cell receptor .
Axicabtagene ciloleucel (KTE-C19, ZUMA-3, YESCARTA) was an investigational therapy (for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)) in which a patient's T cells were 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. [11]
These trials ultimately led in the US to the FDA's first two approvals of CAR T cells in 2017, those for tisagenlecleucel (Kymriah), marketed by Novartis originally for B-cell precursor acute lymphoblastic leukemia (B-ALL), and axicabtagene ciloleucel (Yescarta), marketed by Kite Pharma originally for diffuse large B-cell lymphoma (DLBCL). [15]
Yescarta is a Chimeric Antigen Receptor (CAR) T cell therapy, also known as CAR-T. Moffitt Cancer Center's Frederick Locke, is the co-lead investigator of the pivotal ZUMA-1 clinical trial that tested the new therapy, which is manufactured by Kite, a Gilead company. [32]
Clinical trial number NCT02601313 for "A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)" at ClinicalTrials.gov Clinical trial number NCT02614066 for "A Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia ...
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC.The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial.
In February Kite Pharma announced results from a clinical trial of CAR-T cells in around a hundred people with advanced non-Hodgkin lymphoma. [245] In March, French scientists reported on clinical research of gene therapy to treat sickle cell disease. [246] In August, the FDA approved tisagenlecleucel for acute lymphoblastic leukemia. [247]