Hangzhou Yuzheng Medical Technology Co., Ltd.

Primary objectives: 1) To evaluate the safety and tolerability of HZ-A-018 in patients with relapsed or refractory primary or secondary central nervous system lymphoma; 2) To evaluate the maximum tolerated dose (MTD) and recommended dose (RP2D) of HZ-A-018 in Phase II clinical trials; 3) To evaluate the anti-tumor activity (ORR) of HZ-A-018 in patients with relapsed or refractory primary or secondary central nervous system lymphoma. Secondary objectives: 1) Other efficacy evaluations of HZ-A-018 in patients with relapsed or refractory primary or secondary central nervous system lymphoma, such as CR rate, DOR, DCR, PFS, and OS; 2) To evaluate the pharmacokinetic characteristics of HZ-A-018 in peripheral blood and cerebrospinal fluid. Exploratory objectives: To evaluate the relationship between specific tumor markers and efficacy.

Primary objectives: 1) Evaluate the safety and tolerability of HZ-A-018 in patients with B-cell lymphoma; 2) Recommend the dose (RP2D) for Phase II clinical studies. Secondary objectives: 1) Evaluate the human pharmacokinetic (PK) characteristics of HZ-A-018 in patients with B-cell lymphoma after single and multiple oral administrations; 2) Evaluate the BTK target occupancy of HZ-A-018 in peripheral blood mononuclear cells (PBMCs); 3) Preliminary evaluation of the clinical anti-tumor efficacy of HZ-A-018.