时隔一年,张磊团队再发NEJM:为免疫性血小板减少症带来新疗法
生物世界·2025-06-10 04:00

Core Viewpoint - The research highlights the promising efficacy and safety of anti-CD38 monoclonal antibodies in treating immune thrombocytopenia (ITP), particularly in pediatric patients, indicating a potential new treatment option in this area [1][3][11]. Group 1: Clinical Research Findings - A phase 1/2 clinical study published in NEJM demonstrated that the domestic anti-CD38 monoclonal antibody (CM313) showed good safety and durable efficacy in treating ITP, with 95% of patients achieving a platelet count of at least 50×10^9/L during treatment [1]. - In a subsequent phase 2 study, 90% of pediatric patients with relapsed or refractory ITP responded positively to Daratumumab, with a median time to platelet response of 1 week [7][11]. - The study indicated that 50% of patients maintained a durable response at 24 weeks, comparable to existing second-line therapies [8][11]. Group 2: Safety Profile - The use of Daratumumab was found to be safe, with a low incidence of serious adverse events and no treatment interruptions due to side effects [10]. - The most common adverse events included infusion-related reactions (35%) and upper respiratory infections (30%), which were manageable and did not lead to long-term complications [10].