Youdikai Launches Phase I Clinical Trial of ssCART-19, an IL-6-Knockdown CD19-Targeted CAR-T Therapy for Relapsed/Refractory B-ALL

Recently, Shanghai Unicar-Therapy BioMed-Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Unicar"), a cell therapy enterprise in Zhangjiang Science City, launched its first registered drugClinical Trial“Targeted CD19 Genetically Engineered Autologous T Cell Injection with Silent Interleukin-6 Expression Function (ssCART-19) in CD19-positive Refractory/Relapsed Acute B Lymphoblastic”Leukemia"The clinical study on the safety, tolerability, and preliminary efficacy in patients" project held its kick-off meeting smoothly at the First Affiliated Hospital of Soochow University, marking the Phase I trial of ssCART-19 injection.Clinical TrialOfficially launched and commenced subject recruitment.

Unicar-Therapy, established in 2015, focuses on CAR-T and other cell/Gene TherapyTechnological and product innovations have led to multiple CAR-T products entering the clinical trial application phase. Among them, ssCART-19, indicated for the treatment of refractory/relapsed acute lymphoblastic leukemia (including central nervous system leukemia), received Investigational New Drug (IND) approval in September 2020. Targeting CD19 and incorporating an IL-6 silencing element, this product is expected to significantly reduce the toxic side effects associated with CAR-T clinical applications. Reportedly, this is the first CAR-T therapy worldwide specifically targeting central nervous system leukemia, holding significant importance for the treatment of leukemic central nervous system infiltration.

Currently, UNICAR-THERAPY possesses three production bases with comprehensive GMP manufacturing and quality management/testing systems covering the entire CAR-T production industry chain, including clinical-grade plasmids and lentiviruses.Carrierand the production of CAR-T cells. Under this production management system, over 1,000 cases of real-world clinical studies and compassionate salvage treatments for CAR-T therapy have been completed in collaboration with the hematology departments of multiple renowned large tertiary hospitals in China. (BioValleyBioon.com）

Editor's RecommendationMeeting2021 (12th) International Online Symposium on Cell Therapy

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