Core Points - The clinical trial for PZH2113 capsules, targeting relapsed/refractory B-cell non-Hodgkin lymphoma primarily of diffuse large B-cell lymphoma (DLBCL), has been initiated with a focus on safety, tolerability, pharmacokinetics, and preliminary efficacy [1][2] - The trial is structured in two parts: Part A1/A2 aims to evaluate safety and tolerability, while Part B focuses on preliminary anti-tumor efficacy in MYD88MT DLBCL patients [1][2] - The trial is currently ongoing with a target enrollment of 72 participants [2] Group 1 - The clinical trial registration number is CTR20254688, with the first public information date set for November 25, 2025 [1] - PZH2113 capsules are administered orally once daily, with a treatment cycle of 21 days [1] - The primary endpoints include DLT occurrence rates, adverse events (AE), serious adverse events (SAE), maximum tolerated dose (MTD), and overall response rate (ORR) [2] Group 2 - The drug is a chemical agent indicated for relapsed/refractory B-cell non-Hodgkin lymphoma, characterized by symptoms such as lymphadenopathy, fever, night sweats, and weight loss [1] - Diagnosis relies on pathological biopsy and genetic testing [1] - Secondary endpoints encompass pharmacokinetic parameters, QTc changes, efficacy indicators, and pharmacodynamics (PD) metrics [2]
片仔癀PZH2113胶囊启动Ⅰ期临床 适应症为以弥漫性大B细胞淋巴瘤为主的复发性/难治性B细胞非霍奇金淋巴瘤