Phase Ib Clinical Study of Keynatinib
ConditionLymphoma, B-Cell
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedolution Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Unlimited gender, age ≥ 18 years (including critical value)-Cohort 1/2/3;
Voluntarily participate in the study and sign the ICF, follow the trial treatment protocol and interview plan-Cohort 1/2/3;
Primary central nervous system lymphoma (PCNSL) confirmed by pathology;
For relapsed or refractory PCNSL, at least first line treatment must be given to Central Nervous System (CNS) lesions;
Disqualifiers
Cohort 1: R/R-PCNSL
PCNSL is pathologically diagnosed as T-cell lymphoma;
Chemotherapy, targeted therapy, radiotherapy or antibody based anti-tumor therapy are used within 4 weeks before the first administration or within 5 half-lives (whichever is shorter);
Have previously received the treatment of B Cell Receptor (BCR) inhibitors (such as BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors) or BCL-2 inhibitors (such as ABT-199) or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) or a bispecific antibody drug;
Trial design
Design model
Single group
Treatments tested in this trial
Keynatinib
DrugAll 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Keynatinib treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (CR+PR)
The proportion of subjects whose optimal efficacy observed from the beginning of administration is CR or PR.
Time frame
Every 2 administration cycles in cycle 1-6 and every 3 administration cycles in cycle 7-n.Sponsors and contacts
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Source ClinicalTrials.gov