Lymphoma, B-Cell Clinical Trial
Official title:
An Exploratory Clinical Study of Keynatinib in Relapsed/Refractory B-cell Lymphoma
The purpose of this study is to evaluate the efficacy, safety, PK characteristics in subjects with relapsed/refractory B-cell lymphoma. Furthermore, the relationship between the exposure level of Keynatinib and its efficacy and safety, the penetration rate of keynatinib in the Blood-Brain Barrier (BBB) and its PK characteristics in cerebrospinal fluid in R/R-PCNSL patients, the relationship between the BTK receptor occupancy rate and the efficacy are also evaluated.
This tiral adopts a multi-center, single-arm, multi-cohort, and open-label design to evaluate the efficacy and safety of keynatinib in patients with relapsed/refractory B-cell lymphoma. There will be three cohorts in this trial, details as follows: Cohort 1: R/R-PCNSL subjects; Cohort 2: R/R-CLL/SLL subjects; Cohort 3: R/R-MCL subjects. 10-25 subjects will be enrolled in the R/R-PCNSL, R/R-CLL/SLL, and R/R-MCL cohorts, respectively. ;
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