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 groupLocations
4Cancer Hospital, Chinese Academy of Medical Sciences100021, BeijingBeijing Municipality, China
Peking University Third Hospital100083, BeijingBeijing Municipality, China
Fudan University Shanghai Cancer Center200032, ShanghaiShanghai Municipality, China
West China Hospital，Sichuan University610041, ChengduSichuan, China
Sponsors and collaborators
Medolution Ltd.
Lead sponsor
Source ClinicalTrials.gov