Phase 1b2 Study of HDM2005 With Standard Treatment in Adults 18 to 75 Years Old With Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and antitumor activity of HDM2005 combined with standard treatments in people with diffuse large B-cell lymphoma DLBCL. This phase 1b2 study focuses on two groups those with relapsed or refractory DLBCL and those newly diagnosed without prior treatment. The study is designed to explore appropriate dosing and expand treatment options for these patients. Participants with relapsed or refractory DLBCL Cohort A will receive HDM2005 alongside a combination of rituximab, gemcitabine, and oxaliplatin. Those with untreated DLBCL Cohort B will receive HDM2005 with rituximab, cyclophosphamide, doxorubicin, and prednisone. Treatments are given in cycles every three weeks, with Cohort A receiving up to 6-8 cycles and Cohort B up to 6 cycles. HDM2005 and other drugs are administered intravenously except prednisone, which is taken orally. Throughout the study, participants will undergo regular assessments to monitor side effects, tumor response, and drug levels. Researchers will track dose-limiting toxicities, complete response rates, and other health outcomes for up to several years. The study includes a dose-escalation phase to find the right dose and a dose-expansion phase to further evaluate treatment effects and safety over time.

A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma