NCT04807881

Phase Ib Clinical Study of Keynatinib

An Exploratory Clinical Study of Keynatinib in Relapsed/Refractory B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Medolution Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	Keynatinib	All subjects shall be treated with Keynatinib twice a day (once every 12 hours), 20 mg each time, fasting within 2 hours before and 1 hour after taking the drug, and taking warm water when taking the drug. It is recommended to take the drug at the same time every day. In case of missed administration, the subjects should be instructed to take it as soon as possible when they think of it on the same day. If it is within 3 hours later than the scheduled administration, the study drug should be taken as soon as possible; if the interval is \> 3 hours, skip this time and take the next dose at the normal scheduled time. Do not take double dose at one time. Every 28 days is a treatment cycle until the specified interview completed, PD, intolerable toxicity, death occurs or withdraw from the study (including withdrawal of informed consent by the subject or termination of the study when the investigator judges that the risk is greater than the benefit), whichever occurs first.

Timeline

• Start date: 2020-09-24
• Primary completion: 2027-10-10
• Completion: 2028-04-10
• First posted: 2021-03-19
• Last updated: 2025-01-22

Locations

4 sites across 1 country: China