This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Age ≥ 18 years old.
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to Richter syndrome, transformed follicular lymphoma, transformed MZL) (2016 WHO classification).
Relapse or refractory after receiving 2~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.
Must have a measurable lesion.
Primary or secondary central nervous system (CNS) lymphoma.
Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter), or received therapeutic or palliative radiotherapy within 14 days, or received CAR-T therapy within 12 weeks prior to the administration of the study drugs.
Patients with primary resistance to CDK9 or BTK inhibitors.
Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation within 6 months.