June 15Day,UNICAR-THERAPYAnnouncement, on the29th SessionEuropeHematology AssociationAnnual Meeting (European Hematology Association, EHA）At the annual meeting,Dr. Chen Jia from the First Affiliated Hospital of Soochow University, representing SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTDInAnnounced in the form of an oral reportWith silent interleukinResults of a Multicenter Phase 1/2 Clinical Trial for the CD19-Targeted CAR-T Product with 6 Expression Functions (Product Code: ssCART-19)。
Chen Jia, First Affiliated Hospital of Soochow UniversityPh.D.In2024 EHA Annual Meeting Oral Presentation
ssCART-19Is aWith Silent InterleukinA targeted CD19 gene-engineered autologous T-cell injection with 6 expression functions can simultaneously express the CAR structure and an IL-6 silencing element, significantly reducing the release level of the IL-6 factor. This further decreases monocyte activation and the release of pro-inflammatory cytokines, reducing the incidence of severe cytokine release syndrome (CRS) and severe immune effector cell-associated neurotoxicity syndrome (ICANS) from a preventive perspective, thereby enhancing the safety of CAR-T therapy.At this year's EHA conference, Dr. Chen Jia delivered an oral presentation.ssCART-19Results of Multicenter Phase 1/2 Clinical Trial, This study aims to compareEvaluation of ssCART-19 versus conventional CART-19 cells (cCART-19) in the efficacy and safety for patients with refractory/recurrent B lymphoblastic leukemia (r/r B-ALL). The target population includes those who have previously received at least two lines of therapy.r/r B-ALL patients, there were no significant differences in baseline characteristics among patients.The latest research results show,The safety of the ssCART-19 group (n=47) was significantly better than that of the cCART-19 group (n=40).，The severity of AE in the ssCART-19 group and the incidence of grade 3 and above AEs were lower than those in the cCART-19 group.Mainly manifested inGrade 3-4 neutropenia (ssCART-19 group: 29.79% vs. cCART-19 group: 50%), Grade 3-4 thrombocytopenia (36.17% vs. 45%), Grade 3-4 CRS (14.89% vs. 37.5%), any-grade ICANS (4.26% vs. 15%).AndCompared with the cCART-19 group, the incidence and severity of CRS and ICANS in the ssCART-19 group were significantly reduced.In terms of effectiveness,The ORR of cCART-19 group was 85%, while the ORR of ssCART-19 group was as high as 91.49%.；Besides,The median OS, median PFS, and PFS at 6 months in the ssCART-19 group were significantly higher than those in the cCART-19 group.Existing clinical research results suggest that, compared with conventionalCompared with CART-19 cells, the ssCART-19 product combined with IL-6 gene silencing function has controllable safety and encouraging clinical efficacy in the treatment of r/r B-ALL patients, and is expected to becomeOne of the most promising clinical therapeutic drugs for refractory and relapsed acute lymphoblastic leukemia，For moreOfBring Hope and Treatment Options to Patients.AboutThe First Affiliated Hospital of Soochow University
The First Affiliated Hospital of Soochow University is one of the first Class III Grade A hospitals in China, a provincial hospital directly under the Jiangsu Provincial Health Commission, the Jiangsu Provincial Regional Medical Center, and a high-level, research-oriented, and high-quality development pilot hospital at the provincial level in Jiangsu. In recent years, the hospital has successively received honors such as National Civilized Unit, Advanced Collective in National Hospital Culture Construction, and the Health News Hospital Reform and Innovation Award. The Hematology Department of the First Affiliated Hospital of Soochow University is one of the major centers for the diagnosis and treatment of blood diseases in China. The clinical hematology discipline adheres to the combination of scientific research and clinical practice, focusing on the construction and development of subspecialties. Subspecialty teams have been established, including those for coagulation disorders, leukemia, red blood cell diseases, lymphoma, multiple myeloma, pediatric blood diseases, hematopoietic stem cell transplantation, and specialized hematology nursing teams. These teams undertake several key national and provincial projects.In 2017, the number of outpatient visits exceeded 100,000 cases, with over 10,000 cases admitted to the hospital. More than 651 hematopoietic stem cell transplants were performed, and over 300 new technology treatments such as CAR-T cell therapy were conducted. Patients came from more than 30 provinces, municipalities, and autonomous regions across China.
About UNICAR-THERAPY
SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD (hereinafter referred to as"UNICAR-THERAPY" was established in February 2015 at the Zhangjiang Bio-High Tech Incubation Center in Shanghai, China.，It is a biopharmaceutical company dedicated to the innovation and transformation of global cell therapy technologies, with multiple productsfirst-in-class/first-in-safeThe product is in the clinical trial stage.UNICAR-THERAPY has several original core technology platforms, includingSMART Small Nucleotide Gene Regulation Empowerment Technology Platform, MADDS Antibody Innovation Drugability Technology Platform, 6H Production Quality Control Platform, etc. Moreover, the company has implemented a closed CAR-T production system in Baoshan, with a construction area of approximately 10,000 square meters, for building an internationally advanced billion-level gene and cell therapy research, industrialization, and commercialization center. This will create a world-class immunotherapy tumor innovation technology transfer center and an advanced, high-end genetically engineered immune cell industry chain center, mainly including the industrial production of CAR-T products and CDMO services for plasmids, viruses, and CAR-T cells.UNICAR-THERAPY has a wide range of product pipelines, including products for the treatment of hematological tumors, solid tumors, and autoimmune diseases. The companyInnovative ProductsssCART-19 InjectionCanBreakthrough UseThe treatment of CAR-T contraindications for central nervous system leukemia (commonly known as "brain white") has now entered a critical clinical stage. SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD, in collaboration with the hematology departments of several top-tier tertiary hospitals in China such as Ruijin Hospital and Renji Hospital, has successfully treated over 1000 patients with advanced cancer. The longest survival period of the trial participants with advanced tumors has exceeded 8 years.。
