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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.

Phase 1/2RecruitingGenfleet Therapeutics (Shanghai) Inc.NCT06375733Data as of May 2026

Treatment: GFH009 · Zanubrutinib · GFH009 · ZanubrutinibThis 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)

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 4 prior lines
Min 2 prior lines

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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