Phase Ib Clinical Study of Keynatinib
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 chara
| Condition(s) | Lymphoma, B-Cell |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Unlimited gender, age ≥ 18 years (including critical value)-Cohort 1/2/3; 2. Voluntarily participate in the study and sign the ICF, follow the trial treatment protocol and interview plan-Cohort 1/2/3; 3. The subject's disease diagnosis meets all of the following conditions: Cohort 1: 1. Primary central nervous system lymphoma (PCNSL) confirmed by pathology; 2. For relapsed or refractory PCNSL, at least first line treatment must be given to Central Nervous System (CNS) lesions; 3. Brain Magnatic resonance Imaging (MRI) or Computerized tomography (CT) shows solid lesions of PD; Cohort 2: 1. CLL/SLL diagnosed according to IWCLL 2008 standards; 2. Refractory or relapsed CLL/SLL that previously received at least first-line systemic treatment. First-line treatment is defin |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medolution Ltd. |
| Locations | Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China |
| Start date | 2020-09-24 |
| NCT ID | NCT04807881 |
| Official listing | https://clinicaltrials.gov/study/NCT04807881 |