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 (May 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
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.
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