Large B-cell LymphomaPhase 1/2NCT06375733
A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL
A Phase 1/2 study testing GFH009 and Zanubrutinib in people with Large B-cell Lymphoma, run by Genfleet Therapeutics (Shanghai) Inc. at 2 sites in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma
- What is being tested?
- GFH009 and Zanubrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesChina
- Study dates
- 20 Mar 2024to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to Richter syndrome, transformed follicular lymphoma, transformed MZL) (2016 WHO classification).
- Relapse or refractory after receiving 2~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.
- Must have a measurable lesion.
- The patient is not suitable to receive stem cell transplantation judged by the investigator.
- The Eastern Cooperative Oncology Group (ECOG) performance status score (PS) is 0~2.
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- Have adequate organ function, including:
- Hematopoietic function: absolute neutrophil count (ANC) ≥1.0×109/L, platelet count (PLT) ≥75×109/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.
Who cannot join
- Primary or secondary central nervous system (CNS) lymphoma.
- Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter), or received therapeutic or palliative radiotherapy within 14 days, or received CAR-T therapy within 12 weeks prior to the administration of the study drugs.
- Patients with primary resistance to CDK9 or BTK inhibitors.
- Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation within 6 months.
- Other malignancies within 2 years prior to study entry, excluding appropriately treated carcinoma in situ of the cervix, focal squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle-invasive urothelial carcinoma.
- Have significant diseases of the cardiovascular system or significant acute or chronic infection. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. Presence of significant gastrointestinal disorders. Current clinically significant interstitial lung disease, radiation pneumonitis, or drug-associated pneumonia requiring treatment. Accompanied by other poorly controlled systemic diseases, such as hypertension, diabetes mellitus, etc.
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- Has a history of bleeding disorder or a history of spontaneous bleeding requiring blood transfusion or other medical intervention. Active bleeding within 2 months prior to the first dose.
- Surgical procedures (excluding needle biopsies) that may affect the administration or study evaluation of this study within 28 days prior to the first dose.
- Patients who have been treated with prednisone (or equivalent doses of glucocorticoids) at >20 mg/day for anti-tumor purposes within 7 days, or who require long-term use of glucocorticoids for non-anti-tumor therapy.
- Ongoing medical treatment with a potent inhibitor or inducer of CYP3A is required.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute
Nanning
Cen Hong
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital
Zhengzhou
Keshu Zhou
About this study
Official title: 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)
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
- Large B-cell Lymphoma
- Being tested
- GFH009, Zanubrutinib
- Keywords
- relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
- Medical subject headings
- Recurrence, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH009Drug
administered as an IV infusion at the dose levels 75mg, 60mg, and/or 100mg QW.
ZanubrutinibDrug
administered at 160mg BID oral; 28-day a cycle until disease progresses.
GFH009Drug
the RP2D of GFH009 defined in the preliminary phase 1b trial with the same schedule as in the phase Ib.
ZanubrutinibDrug
administered at 160mg BID oral; 28-day a cycle until disease progresses.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b:GFH009 & Zanubrutinib | Experimental | Not described Receives: Drug: GFH009; Drug: Zanubrutinib |
| Phase 2: GFH009 & Zanubrutinib | Experimental | Not described Receives: Drug: GFH009; Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: adverse events(AEs)
Incidence of DLT events, incidence and severity of AEs and serious adverse events (SAEs), Electrocardiogram changes
Measured: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose, or until the start of a new anti-tumor therapy，assessed up to 32 months
Phase II: ORR
ORR(Objective Response Rate) as assessed by the investigator according to the 2014 Lugano standards
Measured: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose,or until the start of a new anti-tumor therapy, assessed up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keshu Zhou, MD, Principal investigator, Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375733
- Sponsor's protocol ID
- GFH009X1202
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06375733
- Acronym / sponsor ID
- GFH009X1202
- Conditions
- Large B-cell Lymphoma
- Keywords
- relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b:GFH009 & Zanubrutinib | Experimental | Drug: GFH009, Drug: Zanubrutinib |
| Phase 2: GFH009 & Zanubrutinib | Experimental | Drug: GFH009, Drug: Zanubrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old.
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to Richter syndrome, transformed follicular lymphoma, transformed MZL) (2016 WHO classification).
- Relapse or refractory after receiving 2~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.
- Must have a measurable lesion.
- The patient is not suitable to receive stem cell transplantation judged by the investigator.
Key exclusion criteria (10 listed)
- Primary or secondary central nervous system (CNS) lymphoma.
- Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter), or received therapeutic or palliative radiotherapy within 14 days, or received CAR-T therapy within 12 weeks prior to the administration of the study drugs.
- Patients with primary resistance to CDK9 or BTK inhibitors.
- Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation within 6 months.
- Other malignancies within 2 years prior to study entry, excluding appropriately treated carcinoma in situ of the cervix, focal squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle-invasive urothelial carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH009administered as an IV infusion at the dose levels 75mg, 60mg, and/or 100mg QW. | Drug | Phase 1b:GFH009 & Zanubrutinib |
| Zanubrutinibadministered at 160mg BID oral; 28-day a cycle until disease progresses. | Drug | Phase 1b:GFH009 & Zanubrutinib |
| GFH009the RP2D of GFH009 defined in the preliminary phase 1b trial with the same schedule as in the phase Ib. | Drug | Phase 2: GFH009 & Zanubrutinib |
| Zanubrutinibadministered at 160mg BID oral; 28-day a cycle until disease progresses. | Drug | Phase 2: GFH009 & Zanubrutinib |
Primary outcome
Phase Ib: adverse events(AEs)
Time frame: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose, or until the start of a new anti-tumor therapy，assessed up to 32 months
Incidence of DLT events, incidence and severity of AEs and serious adverse events (SAEs), Electrocardiogram changes
Phase II: ORR
Time frame: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose,or until the start of a new anti-tumor therapy, assessed up to 32 months
ORR(Objective Response Rate) as assessed by the investigator according to the 2014 Lugano standards
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keshu Zhou, MD principal investigator
Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GFH009 and Zanubrutinib in people with Large B-cell Lymphoma, run by Genfleet Therapeutics (Shanghai) Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yolanda Zeng (+86 21 6882 1388, yaozeng@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: adverse events(AEs) (time frame: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose, or until the start of a new anti-tumor therapy，assessed up to 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.