Actively Recruiting
A Phase Ib/II, Multicenter, Open-label, Single-arm Study to Assess the Safety and Efficacy of GFH009 in Combination With Zanubrutinib in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2025-08-12
51
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 Ib/II 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.
CONDITIONS
Brief Title
A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or related subtypes according to 2016 WHO classification
- Relapsed or refractory after 2 to 4 systemic treatment regimens, including at least one with anthracyclines and Rituximab
- Presence of a measurable lesion
- Not suitable for stem cell transplantation as judged by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Adequate organ function as defined by specific blood counts and liver, kidney, and coagulation parameters
You will not qualify if you...
- Primary or secondary central nervous system (CNS) lymphoma
- Recent chemotherapy, targeted therapy, immunotherapy, radiotherapy, or CAR-T therapy within specified time frames before study drug administration
- Primary resistance to CDK9 or BTK inhibitors
- History of organ transplantation or allogeneic stem cell transplantation; autologous stem cell transplantation within 6 months
- Other malignancies within 2 years except certain treated cancers
- Significant cardiovascular disease, recent stroke or intracranial hemorrhage, gastrointestinal disorders, interstitial lung disease, or poorly controlled systemic diseases
- History of bleeding disorders or recent active bleeding
- Recent surgical procedures affecting study evaluation
- Recent high-dose prednisone or long-term glucocorticoid use
- Ongoing treatment with strong CYP3A inhibitors or inducers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive GFH009 as an IV infusion once weekly and take Zanubrutinib orally twice daily in repeated 28-day cycles until disease progression or discontinuation.
Duration - Up to 30 days after the last dose
Participants are monitored for safety and outcomes for up to 30 days after the last dose or until starting new anti-tumor therapy.
Trial Site Locations
Total: 2 locations
1
Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute
Nanning, China
Actively Recruiting
2
Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
Y
Yolanda Zeng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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