Status:
WITHDRAWN
A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHL
Lead Sponsor:
BioNova Pharmaceuticals (Shanghai) LTD.
Conditions:
CLL/SLL
NHL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN102 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-...
Detailed Description
The study is divided into 2 phases. Phase1 dose escalation part will enroll 17-36 patients to evaluate safety and tolerance of BN102 in patients with relapsed/refractory (R/R) CLL/SLL and B-NHL to det...
Eligibility Criteria
Inclusion
- All of the following conditions must be met for subject enrollment:
- Have fully understood and voluntarily signed the informed consent form ;
- Age ≥ 18 years;
- In phase 1, subjects with histologically confirmed CLL/SLL or B-cell NHL who are relapsed/refractory or intolerable after at least 1 prior line of adequate therapy, and have no better treatment choice as assessed by the investigator;
- In Phase 2, the 6 cohorts had the following specific enrollment criteria and required further treatment:
- Cohort 1: histologically confirmed MCL, failure or intolerance to at least one prior treatment including BTK inhibitor;
- Cohort 2: histologically confirmed MCL, failure or intolerance to at least 1 prior standard of care (BTK inhibitors naive);
- Cohort 3: histologically confirmed CLL/SLL, failure or intolerance to at least 1 prior treatment including BTK inhibitor;
- Cohort 4: histologically confirmed CLL/SLL, failure or intolerance to at least 1 prior standard of care (BTK inhibitors naive);
- Cohort 5: histologically confirmed other B-NHL, failure or intolerance to at least 1 prior treatment including BTK inhibitor;
- Cohort 6: histologically confirmed other B-NHL, failure or intolerance to at least 1 prior standard of care (BTK inhibitors naive);
- In addition to CLL and WM, subjects must have at least one radiographically measurable lesion
- ECOG score 0-2;
- Male or female patients of childbearing potential must agree to use effective methods of contraception
Exclusion
- Primary central nervous system lymphoma or lymphoma involving the central nervous system;
- Serological status reflects active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
- HIV infection;
- Abnormalities in hematology lab results
- Cardiac, hepatic, renal, and coagulation abnormalities
- Concomitant clinically significant systemic active infection uncontrollable after appropriate antibiotics or other treatment;
- Expected survival of no more than 24 weeks as judged by the investigator;
- Major surgery within 4 weeks prior to the first dose of study drug
- Required or received anticoagulant therapy (warfarin, or equivalent vitamin K antagonist, or direct thrombin inhibitor, or factor Xa inhibitor, etc.) within 7 days prior to the first dose of study treatment;
- Had undergone cell transplantation or chimeric antigen receptor T cell (CAR-T) therapy within 60 days prior to enrollment
- Combined with uncontrolled active immune cytopenia
- Previous treatment with non-covalently binding BTK inhibitors (e.g. LOXO-305, MK-1026, etc.);
- Pregnant (positive pregnancy test at screening) or lactating female patients;
- QTcF \> 450 msec in male patients or QTcF \> 470 msec in female patients or other significant ECG abnormalities as judged by the investigator;
- Toxicities due to prior antilymphoma therapy have not stabilized and have not recovered to ≤ Grade 1 (except for clinically insignificant toxicities such as alopecia, etc.);
- History of other malignancies within 5 years prior to enrollment, special cases must be discussed with the medical monitor;
- Prior systemic anti-tumor therapy or investigational therapy received less than 4 weeks or 5 half-lives (whichever is shorter) from the start of the planned study treatment;
- Use of strong CYP3A inhibitors or inducers and proton pump inhibitors within 1 week or 5 half-lives (whichever is shorter) before administration of the first study drug;
- History of acute myocardial infarction, unstable angina, stroke, intracranial hemorrhage or transient ischemic attack within 6 months prior to enrollment; New York Heart Association (NYHA) grade 3 and 4 congestive heart failure;
- Live viral vaccination within 28 days prior to the first dose of study drug;
- Unable to take oral drugs, or have severe gastrointestinal diseases that investigator believes that it may affect the absorption of the study drug;
- Insufficient compliance of patients participating in this clinical study as judged by the investigator;
- Any other disease or condition in the judgment of the investigator that the patient is not suitable for the study drug, or will affect the interpretation of the study results
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05365100
Start Date
July 1 2022
End Date
July 30 2024
Last Update
March 24 2023
Active Locations (6)
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1
ZhuJiang Hospital of Southern Medical University
Guangzhou, China
2
The First Affiliated School of Guangxi Medical University
Nanning, China
3
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, China
4
The First Affiliated Hospital of Soochow University
Suzhou, China