NCT05365100

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)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-cell Non-Hodgkin's Lymphoma (NHL)

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 determine maximum tolerated dose and recommended phase2 dose(RP2D). Phase 2 expansion part will enroll 72-138 patients and be conducted at the selected dose level to further evaluate the safety and tolerability of BN102,as well as preliminary efficacy in specific subtypes of lymphoma. Patients will be allocated into 6 lymphoma subgroup cohorts depends on whether their previous treatment with or without BTK inhibitors. * Cohort 1: patients with mantle cell lymphoma (MCL) previously treated with BTK inhibitors * Cohort 2: patients with MCL who have not previously received a BTK inhibitor * Cohort 3: patients with CLL/SLL who have received prior BTK inhibitors * Cohort 4: patients with CLL/SLL who have not received prior BTK inhibitors * Cohort 5: other B-NHL patients who have received prior BTK inhibitors * Cohort 6: other B-NHL patients who have not received prior BTK inhibitors Patients will receive orally administrated BN102 twice daily under fasting status. Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity, death, ICF withdraw ect. Subjects may receive study drug in the inpatient or outpatient setting.

Conditions

• CLL/SLL
• NHL

Interventions

Type	Name	Description
DRUG	BN102	oral tablets: BN102, BID

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2022-05-09
• Last updated: 2023-03-24

Locations

6 sites across 1 country: China