RecruitingPhase 1NCT04807881

Phase Ib Clinical Study of Keynatinib

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

Sponsor

Medolution Ltd.

Enrollment

75 participants

Start Date

Sep 24, 2020

Study Type

INTERVENTIONAL

Conditions

Lymphoma, B-Cell

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called keynatinib in people with specific types of blood cancers of the brain and nervous system, or other cancers involving specific genetic mutations, to assess its safety and how well it works. **You may be eligible if...** - You are 18 or older - You have been diagnosed with primary central nervous system lymphoma (brain lymphoma), or another lymphoma/cancer type that meets the study criteria - Your cancer has returned or is not responding to prior treatment - You are willing to follow the treatment and visit schedule **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active serious infections - You have severe heart, liver, or kidney problems - Your cancer type does not match any of the study cohorts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKeynatinib

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.