A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHL

Trial details

Who runs it

BioNova Pharmaceuticals (Shanghai) LTD.

Trial code

NCT05365100

Record updated

2023. március 24.

Original description

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-cell Non-Hodgkin's Lymphoma (NHL)Read full original descriptionShow less

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-cell Non-Hodgkin's Lymphoma (NHL)

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-cell Non-Hodgkin's Lymphoma (NHL)

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: Concomitant clinically significant systemic active infection uncontrollable after appropriate antibiotics or other treatment; 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; Previous treatment with non-covalently binding BTK inhibitors (e.g. LOXO-305, MK-1026, etc.); 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.); 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; Serological status reflects active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection; HIV infection; Cardiac, hepatic, renal, and coagulation abnormalities; History of other malignancies within 5 years prior to enrollment, special cases must be discussed with the medical monitor; Unable to take oral drugs, or have severe gastrointestinal diseases that investigator believes that it may affect the absorption of the study drug; 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; Primary central nervous system lymphoma or lymphoma involving the central nervous system; Abnormalities in hematology lab results; Expected survival of no more than 24 weeks as judged by the investigator; Combined with uncontrolled active immune cytopenia; 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; Insufficient compliance of patients participating in this clinical study as judged by the investigator.

ClinicalTrials.gov NCT05365100