Core Insights - WuXi AppTec's JWCAR201, an autologous CAR-T product targeting CD19/CD20, shows promising initial results in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [1][2] 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 [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 - A total of 7 patients were infused, 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, including 85.7% with DLBCL-NOS, 57.1% with non-GCB subtype, and 57.1% having an International Prognostic Index (IPI) score of ≥3 [2] Group 3: Efficacy Results - The overall response rate (ORR) reached 100% (7/7), with a complete response rate (CRR) of 85.7% (6/7) [2] - All patients except one maintained their response for at least 180 days, indicating significant efficacy [2] Group 4: Safety Profile - Among the 7 patients, 42.9% experienced grade 1 cytokine release syndrome (CRS), and 14.3% had grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) [3] - No high-grade CRS or ICANS were reported, and no dose-limiting toxicities (DLT) occurred, suggesting a manageable safety profile [3] Group 5: Future Prospects - The company believes JWCAR201 demonstrates excellent efficacy and good overall safety, with manageable adverse reactions, indicating strong potential for advancement to the IND stage [3]
药明巨诺-B(02126.HK)：在第67届美国血液学会年会上公布JWCAR201 IIT研究数据