China News Service, Chongqing, January 27 (Liang Qinqing) On January 25, the CAR-T cell product pCAR-19B cell auto-infusion preparation independently developed by Chongqing Precision Biotechnology Co., Ltd. started a phase II registration clinical trial.
The product will be used to treat children and adolescents with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).
Acute lymphoblastic leukemia (ALL) is a malignant proliferative tumor originating from precursor B or T lymphocytes in the bone marrow, blood, and extramedullary, usually in children.
Globally, ALL is still dominated by chemotherapy.
The pCAR-19B product is the first CAR-T product in China that has entered the Phase II clinical registration for children and adolescents with relapsed/refractory B-ALL indications, and has independent intellectual property rights.
CAR-T therapy (chimeric antigen receptor T-cell immunotherapy) is a new type of precision targeted therapy for the treatment of tumors.
In layman's terms, it is to activate T cells and install the positioning and navigation device CAR (Tumor Chimeric Antigen Receptor) to transform the ordinary "warrior" of T cells into "super soldiers" - CAR-T cells, which specifically recognize and efficiently Kill tumor cells in the patient's body to achieve targeted therapy for tumor patients.
The reporter inquired on the website of the Center for Drug Evaluation of the State Drug Administration that there are only two CAR-T products for children and adolescents with relapsed/refractory B-ALL indications, except Chongqing Precision Biotechnology Co., Ltd. , the products developed by Beijing Yongtai Ruike Biotechnology Co., Ltd. are still in Phase I, and the products developed by Novartis (China) Biomedical Research Co., Ltd./Shanghai Saibiman Biotechnology Co., Ltd. have entered Phase II, but Novartis is a headquarters An offshore company based in Basel, Switzerland.
The key phase II registration clinical trial of pCAR-19B product is a multi-center clinical trial. Clinical trials will be carried out in more than 10 tertiary hospitals in China, with Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology and Beijing Children's Hospital affiliated to Capital Medical University as the leading units. Patient recruitment to evaluate the efficacy of pCAR-19B products in the treatment of children and adolescents with relapsed/refractory leukemia.
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