Actively Recruiting
A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2025-08-12
51
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
CONDITIONS
Official 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), including subtypes such as T-cell/histiocyte-rich large B-cell lymphoma, high-grade B-cell lymphoma, or transformed indolent B-cell lymphoma
- Relapsed or refractory after 2 to 4 systemic treatment regimens, with at least one regimen containing 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 including: hematopoietic function (ANC ≥1.0 ×10⁹/L, platelet count ≥75 ×10⁹/L, hemoglobin ≥80 g/L), liver function (total bilirubin ≤1.5 × upper limit of normal, AST and ALT ≤2.5 × upper limit of normal), renal function (serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥50 mL/min if serum creatinine >1.5 × upper limit of normal), and coagulation function (INR and APTT ≤1.5 × upper limit of normal)
You will not qualify if you...
- Presence of primary or secondary central nervous system lymphoma
- Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect, investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter)
- Received therapeutic or palliative radiotherapy within 14 days
- Received CAR-T therapy within 12 weeks prior to 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 prior to study entry, except certain treated cancers such as carcinoma in situ of the cervix or basal cell carcinoma
- Significant cardiovascular diseases, acute or chronic infections, recent stroke or intracranial hemorrhage within 6 months, gastrointestinal disorders, interstitial lung disease, radiation pneumonitis, or drug-associated pneumonia requiring treatment
- History of bleeding disorders or active bleeding within 2 months prior to first dose
- Surgical procedures (excluding needle biopsies) within 28 days prior to first dose that may affect study treatment or evaluation
- Use of prednisone or equivalent glucocorticoids at >20 mg/day for anti-tumor purposes within 7 days, or long-term glucocorticoids for non-anti-tumor therapy
- Ongoing treatment with a potent CYP3A inhibitor or inducer
AI-Screening
AI-Powered Screening
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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
CONTACT
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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