The first car-t cell therapy for mantle cell lymphoma (MCL) in the world! Gilead second cell therapy kte-x19 in the United States to apply for listing!

December 13, 2019 / BIOON / -- kit, a T-cell treatment company owned by Gilead, recently announced that it has submitted to the U.S Food and Drug Administration (FDA) a biological product licensing application (BLA) for car-t-cell therapy kte-x19 for the treatment of adult patients with recurrent or refractory mantle cell lymphoma (R / R MCL) Kit also plans to submit a marketing authorization application (MAA) for kte-x19 in the EU in early 2020 Previously, kte-x19 has been awarded breakthrough drug qualification (BTD) by FDA and priority drug qualification (prime) by European Drug Administration (EMA) to treat relapsed or refractory MCL Kte-x19 is also kit's second car-t cell therapy for regulatory applications, marking a potential expansion of its cell therapy portfolio If approved, kte-x19 has the potential to become the first car-t cell therapy for MCL MCL is a rare non-Hodgkin's lymphoma (NHL), which originates from the "mantle" cells of lymph nodes and usually affects men over 60 years old The BLA is based on data from phase II clinical study zuma-2 This study is a single arm, multicenter, open label study involving 74 adult patients with MCL The disease of these patients has no effect or relapse on 5 previous treatment regimens (including anthracycline based or bendamoxetine based chemotherapy regimens, anti-CD20 monoclonal antibody drugs, Btk inhibitor ibrutinib or acalabrutinib) Objective to evaluate the efficacy (60 cases) and safety (68 cases) of kte-x19 after single infusion The results showed that after kte-x19 single infusion, the overall response rate (ORR) and complete response rate (CR) assessed by the independent radiology Review Committee (irrc) were 93% and 67%, respectively In terms of safety, 15% and 31% of patients with level 3 or above of CRS and neurological events respectively occurred, and no level 5 CRS or neurological events occurred Ken Takeshita, MD, director of global clinical development at kit, said: "although some progress has been made in recent years, new treatment methods are still needed for patients with recurrent / refractory MCL, so the submission of this regulatory document is a particularly important milestone for the MCL community We look forward to working with FDA to bring kte-x19 to the right patients as soon as possible, and continue to fulfill our industry-leading cell therapy development project promise through the second car-t therapy " T cell therapy is a promising therapeutic method, and kit is a leading enterprise in this field At the end of August 2017, Geely Dehao invested $12 billion to acquire kite and enter the field In October 2017, kit's first car-t cell therapy, yescarta (axicabagene ciloleucel, kte-c19), was approved by the U.S FDA and became the first car-t therapy approved to treat DLBCL in the world This therapy is also the second car-t therapy approved to market after Novartis kymariah (tisagenlecleucel-t, ctl019) The principle of yescarta and kymriah is to genetically modify the T cells of patients to express the chimeric antigen receptor (car) targeting the antigen CD19 CD19 is an antigen protein expressed on the surface of a variety of blood tumor cells, including B-cell lymphoma and leukemia cells The transformed T cells were infused back to the patient to recognize and attack the CD19 expressing tumor cells and other B cells Kte-x19 is a kind of research, autogenous and anti-cd19-car T-cell therapy, which adopts XLP manufacturing process, including T-cell screening and lymphocyte enrichment For some B-cell malignancies with evidence of circulating lymphoblasts, lymphocyte enrichment is a necessary step Kte-x19 is currently undergoing phase I / II clinical trials for the treatment of acute lymphoblastic leukemia (all), mantle cell lymphoma (MCL) and chronic lymphoblastic leukemia (CLL) Original source: Kit submissions biology license application to U.S Food and Drug Administration for company's second car T cell therapy