A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies

BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib/II clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.

NCT Number	NCT07609862
Lead Sponsor	Guangzhou Lupeng Pharmaceutical Company LTD.
Conditions	Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL), Waldenström Macroglobulinemia (WM), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Enrollment	92 participants
Start Date	2026-07-14
Primary Completion	2029-06-30 (estimated)
Study Completion	2033-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-30