Actively Recruiting
Exploratory Study of Keynatinib Treatment in Relapsed or Refractory B-cell Lymphoma
Led by Medolution Ltd. · Updated on 2025-01-22
75
Participants Needed
4
Research Sites
393 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and pharmacokinetics of Keynatinib in adults with relapsed or refractory B-cell lymphoma. The study also explores the drug's ability to cross the blood-brain barrier in patients with relapsed/refractory primary central nervous system lymphoma (R/R-PCNSL) and examines the relationship between drug exposure, BTK receptor occupancy, and treatment outcomes. This is a phase 1, multi-center, single-arm, open-label trial with multiple cohorts based on lymphoma subtype. Participants will be divided into three groups: those with R/R-PCNSL, relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R-CLL/SLL), and relapsed/refractory mantle cell lymphoma (R/R-MCL). All subjects will receive Keynatinib orally twice daily at 20 mg per dose, taken with warm water while fasting around dosing times. Each treatment cycle lasts 28 days and continues until disease progression, unacceptable toxicity, death, withdrawal, or study termination. Approximately 10 to 25 subjects will be enrolled per cohort. During the study, participants will have regular assessments including imaging scans such as MRI or CT to monitor tumor response every 2 to 3 treatment cycles. Researchers will measure the objective response rate and track safety and pharmacokinetics throughout the trial. Other evaluations include laboratory tests, BTK receptor occupancy, cerebrospinal fluid analysis in certain patients, and monitoring for adverse effects. The study aims to understand how well Keynatinib works and how it is processed in the body over time.
CONDITIONS
Official Title
Phase Ib Clinical Study of Keynatinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Voluntary participation with signed informed consent
- Diagnosis of relapsed or refractory B-cell lymphoma meeting cohort-specific criteria: Cohort 1: Pathologically confirmed primary central nervous system lymphoma (PCNSL) with prior first-line CNS lesion treatment and measurable progressive lesions on MRI or CT Cohort 2: Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) diagnosed by IWCLL 2008 standards, refractory or relapsed after at least one systemic treatment, with measurable lesions on CT/MRI Cohort 3: Mantle cell lymphoma confirmed by histopathology with prior treatment failure of 1 to 3 chemotherapies or targeted drugs and measurable lesions on CT/MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Estimated survival of at least 4 months
- Adequate organ function including specified blood counts and liver, kidney, and coagulation parameters
- Fertile female subjects must agree to use effective contraception or abstinence during the study and for 90 days after last dose; male subjects must use contraception and avoid sperm donation for 90 days after last dose
You will not qualify if you...
- PCNSL patients with T-cell lymphoma diagnosis
- Recent treatment within 4 weeks or 5 half-lives of chemotherapy, targeted therapy, radiotherapy, antibody therapy, BCR inhibitors, BCL-2 inhibitors, CAR-T, or bispecific antibodies
- Prior allogeneic hematopoietic stem cell transplant or other organ transplant (except autologous SCT over 6 months ago)
- Use of high-dose corticosteroids or immunosuppressants as specified
- Other malignancies within 3 years except certain curable skin, bladder, cervical, or breast cancers
- Unresolved toxicities from prior treatments above grade 1 (except hair loss)
- Severe or uncontrolled cardiovascular diseases including heart failure, arrhythmia, cardiomyopathy, prolonged QTc, or uncontrolled hypertension
- Active bleeding or bleeding tendency, history of deep vein thrombosis or pulmonary embolism
- Recent stroke or intracranial hemorrhage within 6 months
- Significant gastrointestinal conditions affecting drug absorption
- Serious or active infections including uncontrolled HIV, hepatitis B or C
- History of pulmonary fibrosis, interstitial pneumonia, or severe lung impairment
- Major surgery within 4 weeks before first dose without recovery
- Participation in other clinical trials within 4 weeks before screening
- History of alcohol or drug abuse
- Pregnant or lactating women
- Concurrent use of strong CYP3A inhibitors or inducers
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083
Actively Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
4
West China Hospital，Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
J
Jin Yan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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