OncoMatch/Clinical Trials/NCT06375733
A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL
Is NCT06375733 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including GFH009 and Zanubrutinib for large b-cell lymphoma.
Treatment: GFH009 · Zanubrutinib · GFH009 · Zanubrutinib — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline
at least one of which contains anthracyclines
Must have received: (rituximab)
at least one of which contains ... Rituximab
Cannot have received: chemotherapy
Exception: within 28 days or 5 half-lives (whichever is shorter) prior to study drugs
Received chemotherapy ... within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: targeted therapy
Exception: within 28 days or 5 half-lives (whichever is shorter) prior to study drugs
Received ... targeted therapy ... within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: endocrine therapy
Exception: within 28 days or 5 half-lives (whichever is shorter) prior to study drugs
Received ... endocrine therapy ... within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: immunotherapy
Exception: within 28 days or 5 half-lives (whichever is shorter) prior to study drugs
Received ... immunotherapy ... within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: (Chinese patent medicine with anti-tumor effect)
Exception: within 28 days or 5 half-lives (whichever is shorter) prior to study drugs
Received ... Chinese patent medicine with anti-tumor effect ... within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: investigational drug
Exception: within 28 days or 5 half-lives (whichever is shorter) prior to study drugs
Received ... other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: radiation therapy
Exception: within 14 days prior to study drugs
received therapeutic or palliative radiotherapy within 14 days
Cannot have received: CAR-T cell therapy
Exception: within 12 weeks prior to the administration of the study drugs
received CAR-T therapy within 12 weeks prior to the administration of the study drugs
Cannot have received: CDK9 inhibitor
Exception: primary resistance
Patients with primary resistance to CDK9 ... inhibitors
Cannot have received: BTK inhibitor
Exception: primary resistance
Patients with primary resistance to ... BTK inhibitors
Cannot have received: allogeneic stem cell transplantation
Has a history of organ transplantation or allogeneic stem cell transplantation
Cannot have received: autologous stem cell transplantation
Exception: within 6 months
Patients who have undergone autologous stem cell transplantation within 6 months
Lab requirements
Blood counts
ANC ≥1.0×10^9/L, PLT ≥75×10^9/L, Hgb ≥ 80 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN, or serum creatinine clearance ≥ 50 mL/min when Cr > 1.5× ULN
Liver function
total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN
Have adequate organ function, including: Hematopoietic function: absolute neutrophil count (ANC) ≥1.0×10^9/L, platelet count (PLT) ≥75×10^9/L and hemoglobin (Hgb) ≥ 80 g/L. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN, or serum creatinine clearance ≥ 50 mL/min when Cr > 1.5× ULN. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06375733 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, endocrine therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify