Chongqing, January 26 news On January 25, Chongqing Precision Biotechnology Co., Ltd. (hereinafter referred to as Chongqing Precision Bio) independently developed car-T cell product pCAR-19B cell autologous reinfusion preparation Phase II registered clinical trial was launched, which will be used to treat children and adolescents relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL).
Tongji Hospital Kick-off Meeting (Courtesy of Chongqing Precision Biotechnology Co., Ltd.)
The product was approved by the Children's B-ALL Indications Registered Clinical Implied License in February 2019, which is the first CAR-T product in China to enter the Phase II registered clinical trial for this indication, and the first HUMAN-based CAR-T product designed for this indication in China, showing good safety and efficacy in previous clinical studies.
CAR-T therapy (chimeric antigen receptor T cell immunotherapy) is a novel precision-targeted therapy for the treatment of tumors. In layman's terms, it is to activate T cells and install a positioning navigation device CAR (tumor chimeric antigen receptor), transform the ordinary "warrior" of T cells into a "super soldier" - CAR-T cells, specifically identify and efficiently kill tumor cells in patients, and realize targeted treatment for tumor patients.
It is worth mentioning that the CD19 CAR-T cell products that have been approved for marketing use murine antibodies as ScFV, which have high immunogenicity and are easily recognized and cleared by the body's immune system, reducing the survival time of CAR-T cells in vivo. The humanized CD19 CAR-T of pCAR-19B independently developed by Chongqing Precision Bio can reduce the immunogenicity of CAR-T cells, prolong the survival time of CAR-T cells in vivo, and thus reduce the tumor recurrence rate.
According to reports, the product launched a Phase I registered clinical trial in November 2019, and 9 patients with B-ALL in children or adolescents who met the inclusion criteria received pCAR-19B cell therapy, all of which were refractory or patients who relapsed after multi-line treatment, and more than half of the subjects were patients with high tumor load. The data showed that 9 patients achieved complete response (CR) with an overall response rate of 100%, and the micro residual lesions (MRD) of patients who achieved complete response (CR) for the first time were also negative; no dose-limiting toxicity (DLT) and treatment-related deaths occurred, and the overall safety and tolerability were good.
The test is in progress (Courtesy of Chongqing Precision Biotechnology Co., Ltd.)
"Chongqing Precision Biology is committed to the development of R&D pipelines and the development of technical platforms around the core issues of malignant tumor cell therapy, and constantly seeks double breakthroughs in hematological tumors and solid tumors, and has more than 10 CAR-T R&D pipelines such as leukemia, lymphoma, myeloma, lymphoma, gastrointestinal cancer, lung cancer, liver cancer, breast cancer, and pancreatic cancer." At present, it has obtained 2 car-T cell national first-class biological new drugs and five indications of registered clinical implied licenses. As an innovative car-T drug with independent intellectual property rights in China, pCAR-19B is expected to bring new treatment options and hopes to chinese children and adolescents with recurrent/refractory leukemia. The relevant person in charge of the company's clinical center was introduced.
R&D environment (Courtesy of Chongqing Precision Biotechnology Co., Ltd.)
It is understood that the key Phase II registered clinical trial of pCAR-19B products is a multicenter clinical trial to evaluate the effectiveness of pCAR-19B in the treatment of recurrent/refractory leukemia in children and adolescents. Adult r/r B-ALL indications for pCAR-19B cell autologous reinfusion preparations are being clinically conducted, and the overall response rate is also 100%.
R&D personnel Dr. Yao Chao (Courtesy of Chongqing Precision Biotechnology Co., Ltd.)
pCAR-19B cell autologous reinfusion preparation is a national class of biological new drugs, the product has been approved for children, adolescents relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL), adult relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL) and B cell non-Hodgkin lymphoma (B-NHL) three indications.
The pCAR-19B cell autologous refusion preparation is independently developed by Chongqing Precision Biotechnology Co., Ltd., has the protection of invention patents, and is a cellular immunotherapy product developed for malignant hematologic diseases of CD19-positive B cell origin, and was approved by the State Food and Drug Administration to carry out clinical trials in February 2019. pCAR-19B is optimized for Chinese populations with CAR (Chimeric antigen receptor) structure for better efficacy and safety. Future indications for pCAR-19B will extend to other malignant diseases such as chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin lymphoma (B-NHL). (Text/Wang Hai)