2018-07-26 00:00 百暨临床
Two thousand and eighteen year Seven month Twenty-five Day, my company CAR-T product " Targeting CD19 The modified autologous chimeric antigen receptor T Cell injection " (code: BG-T19 The clinical application was registered) CDE Undertake。
BG-T19 Is my company independent research and development CAR-T The use of the product, the company's core technology TscmRICH . Through a series of cell sorting, activation, amplification, amplification with memory characteristics of stem cells T The ability of anti tumor cells, to ensure the long-term.
The submission of the CAR-T The cell product is aimed at two indications IND Application: for children and young adults with refractory recurrent acute B Lymphocytic leukemia and the treatment of aged and adult patients with relapsed and refractory diffuse large B Cell lymphoma.
CXSL1800078 Country: targeting CD19 The modified autologous chimeric antigen receptor T Cell - injection therapy in children and young adults with refractory recurrent acute B Lymphocytic leukemia
Refractory recurrent acute B Lymphocytic leukemia ( R/r B-ALL ) is a kind of origin in lymphocytes B Malignant cells in bone marrow dysplasia. The abnormal proliferation of primitive cells in the bone marrow and inhibit the aggregation of normal hematopoietic function, but also can invade the tissue such as bone marrow, meninges, lymph nodes, gonad, liver etc.. B-ALL The clinical manifestations of leukemia cell proliferation and invasion, the main manifestations are: ( One Early manifestations of anemia), fever, fatigue, weakness, joint pain; bone; skin pale mucosa; skin bleeding, bruising, epistaxis; liver, spleen, lymph nodes and other infiltration. ( Two ) change: blood hemoglobin and red blood cell count were decreased, thrombocytopenia, lymphocyte ratio increased, the classification can be found in varying amounts of primitive and immature lymphocytes. ( ThreeCentral nervous system leukemia). ( Four Testicular leukemia). ALL The treatment plan is numerous, mainly pre treatment, remission induction therapy and consolidation therapy for early and late, to strengthen the prevention and treatment of central nervous system leukemia. However, compared with the current standard therapy, BG-T19 Better clinical treatment effect, especially in the complete remission rate and total survival rate, the advantage is obvious, and shows good safety.
Diffuse large B Cell lymphoma ( DLBCL ) is primary, but also by other low aggressive lymphoma progression or transformation and. R/r DLBCL The main cause of disease resistance, the resistance mechanism is mainly divided into: congenital resistance, acquired drug resistance and tumor cell microenvironment / Cell adhesion mediated drug resistance. DLBCL Adult non Hodgkin's lymphoma ( NHL ) in the incidence of a pathological type is the highest, the complete remission rate is low, high resistance rate. DLBCL The clinical manifestations, the rapid increase of painless mass for the typical performance, common sites of gastrointestinal tract, can also occur in the skin, skeletal and central nervous system, mediastinum, lung, liver and spleen, genital and Waldeyer's ring etc.. At present R/r DLBCL The treatment method, the main choice is the other CHOP The drug is not cross resistant to second-line chemotherapy (e.g. ICE , ESHAP , DHAP , Gross domestic product Plan) . Rituximab or individualized. For hard to treat /Recurrent diffuse large B Cell lymphoma ( R/r DLBCL ), were treated by combined therapy at present average CR Not to 30% The total efficiency, not to 50% There are serious adverse reactions, bone marrow toxicity, median OS Short. Targeting CD19 The CAR-T about R/r DLBCL The patient can produce excellent efficacy outcomes, mainly for toxicity CRS And most of the patients in the infusion of neurotoxicity. One Months after the intervention and adequate treatment can be solved. Clinical research data show that the therapy in adult R/r DLBCL Patients with higher remission rate and safety control.
Guangzhou 100 & Gene Technology Co. Ltd was founded in Two thousand and fifteen Seven years, is a subsidiary of group holdings. HEDY holding group is a large group, private enterprises, major health industry layout, involves many fields of pharmaceutical development, medical equipment, private hospitals and cell therapy etc..
We have established long-term cooperative relationship with the world's top cell therapy team and domestic universities, and in the past Ten A cooperative clinical hospital, the formation of complementary advantages and focus the development and production of bio pharmaceutical drugs to the bit to the development of a new generation of antibody and target group.
At present, the seven group Teresa accelerated in the establishment of medical Twenty Cancer hospital, clinical trials have provided abundant resources and broad market space for our products.
In the future, we consolidate the foundation of blood tumor, solid tumor will increase, HIV Antibody drug, generic type CAR-T Tumor antigen vaccine, new investment, at the forefront of biotechnology for saving lives, another miracle.