药明巨诺-B(02126)：在第67届美国血液学会年会上公布JWCAR201 IIT研究数据

Core Viewpoint - WuXi AppTec's JWCAR201, an autologous CAR-T product targeting CD19/CD20, shows promising preliminary efficacy and safety in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients, as presented at the 67th American Society of Hematology Annual Meeting [1][4]. Group 1: Study Overview - The study is a single-arm, open-label, multi-center, dose-exploration IIT research conducted in China, evaluating JWCAR201's safety and preliminary efficacy in DLBCL patients [1]. - The initial dose was set at 25×10^6 CAR+ T cells, with exploration at three dose levels: 25×10^6, 50×10^6, and 100×10^6 CAR+ T cells [1]. Group 2: Patient Demographics and Characteristics - A total of 7 patients were infused with JWCAR201, with a median age of 56 years (range: 42 to 72 years), and 42.9% were male [2]. - The patient cohort exhibited high-risk characteristics: 85.7% had DLBCL-NOS, 57.1% were non-GCB subtype, and 57.1% had an International Prognostic Index (IPI) score of ≥3 [2]. - 42.9% of patients had received ≥3 lines of prior treatment, and 85.7% were resistant to their most recent treatment [2]. Group 3: Efficacy Results - Preliminary results indicated a best overall response rate (ORR) of 100% (7/7) and a complete response rate (CRR) of 85.7% (6/7) among the infused patients [2]. - All responses were sustained for at least 180 days, with median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) yet to be reached, indicating significant efficacy [2]. Group 4: Safety Profile - Safety results showed that 42.9% of patients experienced grade 1 cytokine release syndrome (CRS), and 14.3% experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) [3]. - No high-grade CRS or ICANS occurred, and no dose-limiting toxicities (DLT) were reported [3]. - Treatment-related adverse events were manageable and included expected hematologic toxicities, which resolved to baseline or fully recovered [3]. Group 5: Future Outlook - The study is ongoing to gather longer follow-up data, and the company believes JWCAR201 demonstrates excellent efficacy and manageable safety, showing significant potential for rapid advancement to the IND stage [4].