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
Qualifiers
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
Treatments tested in this trial
- Keynatinib
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov