This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R/R non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic "3+3" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.
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.
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 of study treatment.