Shenzhen Zhenxingbeite Pharmaceutical Technology Co., Ltd.

The main purpose of the Ia dose escalation phase is to evaluate the tolerability and safety of ZXBT-1158 capsules in the treatment of advanced relapsed and refractory B-cell malignancies and determine the MTD. Secondary objectives: To evaluate the preliminary efficacy of ZXBT-1158 capsules in the treatment of advanced relapsed and refractory B-cell malignancies; to evaluate the human pharmacokinetic (PK) characteristics of single and multiple oral ZXBT-1158 capsules in patients with relapsed and refractory B-cell malignancies; to evaluate the degree of inhibition of BTK in peripheral blood mononuclear cells (PBMCs) by ZXBT-1158 capsules. The main purpose of the Ib dose expansion phase is to evaluate the safety and dose tolerance of ZXBT-1158 capsules in the treatment of relapsed and refractory peripheral B-cell malignancies, primary or secondary central nervous system lymphomas, and determine the RP2D. Secondary objectives: To further evaluate the preliminary efficacy of ZXBT-1158 capsules in the treatment of relapsed and refractory peripheral B-cell malignancies, primary or secondary central nervous system lymphomas; To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral ZXBT-1158 capsules in patients with relapsed and refractory peripheral B-cell malignancies, primary or secondary central nervous system lymphomas; To evaluate the degree of inhibition of BTK in peripheral blood mononuclear cells (PBMCs) by ZXBT-1158 capsules. Exploratory objectives: To explore the concentration of ZXBT-1158 in the cerebrospinal fluid of patients with primary or secondary central nervous system lymphomas.