A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Inclusion Criteria: * Patients with relapsed or refractory non-GCB DLBCL. * Have at least one measurable lesion according to the Lugano Response Criteria 2014. * ECOG performance status 0-2 (0-1 for dose escalation part). * Life expectancy ≥ 12 weeks. * Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function. * No plan for autologous/allogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy. * Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0. * All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating * Subjects must provide adequate tissue and blood samples for exploratory study. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule. Exclusion Criteria: * Intolerance to Rocbrutinib or any drug in the combination regimen. * Prior treatment with a BTK-targeted therapy; prior treatment with R-GemOx. * DLBCL transformed from an indolent lymphoma; diagnosis of high-grade or double-hit DLBCL. * Chemotherapy, biologic therapy (except CAR-T), immunotherapy or major surgery within 4 weeks of the first dose …