Clinical trial · Interventional
A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHL
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to company decision
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL/SLL | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ALIAS | 0.90 |
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BN102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Phase1dose escalation
- description
- Phase1 Dose Escalation Multiple dose levels of BN102 to be evaluated; determination of MTD/Phase 2 recommended dose(RP2D)
- interventionNames
- Drug: BN102
- type
- EXPERIMENTAL
- label
- Phase2 expansion in R/R MCL with BTK inhibitor treatment history
- description
- patients must have received at least one systemic treatment and failed or relapsed, patients previous treatment should with BTK inhibitor, approximate 12-23 patients this group
- interventionNames
- Drug: BN102
- type
- EXPERIMENTAL
- label
- Phase2 expansion in R/R MCL without BTK inhibitor treatment history
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: * 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
References
Publications (0)
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