启函生物公布“现货型”CAR-T细胞治疗多种自身免疫疾病中的临床数据及in vivo CAR-T临床前数据

Core Viewpoint - The article highlights the promising clinical results of QI-019B, a universal allogeneic CAR-T cell product developed by Qihuan Biotech, which targets multiple autoimmune diseases and has shown good safety and efficacy in clinical trials [2][6]. Group 1: Clinical Results - QI-019B demonstrated good treatment tolerance in a clinical trial involving 20 subjects, with no events exceeding grade 1 for cytokine release syndrome (CRS) and no reports of immune effector cell-associated neurotoxicity syndrome (ICANS) or severe infections [2][3]. - In the trial, 19 subjects received therapeutic doses, showing clinical benefits, while one subject receiving a sub-therapeutic dose was not included in the efficacy summary [3]. - Specific results include: - Systemic lupus erythematosus-related immune thrombocytopenia (SLE-ITP): 6 subjects, with 5 achieving complete remission and normal platelet counts, and 1 achieving partial remission [4]. - Antiphospholipid syndrome-related immune thrombocytopenia (APS-ITP): 5 subjects, with 4 achieving complete remission and normal platelet counts [8]. - Autoimmune hemolytic anemia (AIHA): 3 subjects, with 2 achieving complete remission and normal hemoglobin levels [8]. - Systemic lupus erythematosus (SLE): 2 subjects, with 1 meeting DORIS remission criteria and 1 achieving SRI-4 response by the second month [8]. - Neurological autoimmune diseases: 3 subjects, currently under follow-up [8]. Group 2: Product Development and Regulatory Status - QI-019B has received clinical trial approval from the FDA and NMPA for refractory systemic lupus erythematosus (rSLE), with the FDA granting fast track designation for the SLE-ITP indication [6]. - The product is based on a unique "immune evasion" platform that utilizes advanced gene editing to create low immunogenicity cells, aiming to overcome challenges in CAR-T therapy such as immune rejection and reliance on lymphocyte depletion [6][7]. - The company is also developing the next-generation product QI-019C, which aims to further reduce immunogenicity and eliminate the need for external cell factors to enhance expansion [6][7].