Phase IbII Study of GFH009 and Zanubrutinib Combination Therapy for Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma DLBCL

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination of two drugs, GFH009 and Zanubrutinib, in patients with relapsed or refractory diffuse large B-cell lymphoma DLBCL, including several specific subtypes. This multicenter, open-label phase IbII study focuses on patients who have already undergone multiple treatments but still have active disease and are not suitable for stem cell transplantation. The study involves administering GFH009 through intravenous infusion at varying dose levels once weekly, alongside Zanubrutinib taken orally twice daily in 28-day cycles until the disease progresses. The trial has two phases Phase Ib to assess safety and dosing, followed by Phase II to evaluate the overall response rate using the recommended Phase 2 dose established earlier. Participants will be monitored from screening through 30 days after the last dose or until starting new anti-tumor therapy, with assessments covering adverse events and treatment responses over up to 32 months. The study includes detailed evaluations of organ function and performance status, with continuous safety monitoring throughout the treatment period.

A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL