Core Viewpoint - WuXi AppTec's JWCAR201, an autologous CAR-T product targeting CD19/CD20, shows promising safety and efficacy in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) based on preliminary data from an ongoing IIT study presented at the 67th American Society of Hematology Annual Meeting [1][4]. Group 1: Study Overview - The IIT study is a single-arm, open-label, multi-center, dose-exploration trial conducted in China, evaluating JWCAR201 at three dose levels: 25×10^6, 50×10^6, and 100×10^6 CAR+ T cells [1]. - As of October 30, 2025, seven patients have been infused with JWCAR201, completing safety, efficacy, pharmacokinetics, and pharmacodynamics assessments across the three dose groups [1]. Group 2: Patient Characteristics - The median age of the seven patients is 56 years (range: 42 to 72 years), with 42.9% being male [2]. - The patient cohort exhibits high-risk characteristics: 85.7% have DLBCL-NOS, 57.1% are non-GCB subtype, 57.1% have an International Prognostic Index (IPI) score of ≥3, and 71.4% have double-expressor lymphoma (MYC/BCL2) [2]. - 42.9% of patients had received three or more lines of prior treatment, with 71.4% being primary refractory and 85.7% being resistant to their most recent treatment [2]. Group 3: Efficacy Results - Preliminary results indicate 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 six patients who achieved a response maintained it up to Day 180 or longer, with median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) yet to be reached, suggesting significant efficacy [2]. Group 4: Safety Profile - Initial safety results show 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), with no high-grade CRS or ICANS reported [3]. - All patients experienced treatment-related adverse events, primarily manageable hematologic toxicities, including neutropenia, thrombocytopenia, and anemia, which resolved to baseline or fully recovered [3]. - The safety profile indicates that JWCAR201 treatment for r/r DLBCL is manageable and controllable [3]. Group 5: Future Outlook - The study is ongoing, aiming to accumulate longer follow-up data [4]. - Based on the results, the company believes JWCAR201 demonstrates excellent efficacy and a favorable safety profile, showcasing significant potential for rapid advancement to the IND stage [4].
药明巨诺-B：在第67届美国血液学会年会上公布JWCAR201 IIT研究数据