RecruitingPhase 1Phase 2NCT06375733

A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL

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)


Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Enrollment

51 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — GFH009 (a CDK4/6 inhibitor) and zanubrutinib (a BTK inhibitor) — in people with a type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory DLBCL or a related large B-cell lymphoma - You have already tried 2 to 4 previous treatment regimens, including at least one that contained both an anthracycline (a type of chemotherapy) and rituximab - You are not a suitable candidate for a stem cell transplant - You have at least one measurable tumor **You may NOT be eligible if...** - Your lymphoma has not yet been treated - You have only tried one previous treatment - You are eligible for and willing to undergo a stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGFH009

administered as an IV infusion at the dose levels 75mg, 60mg, and/or 100mg QW.

DRUGZanubrutinib

administered at 160mg BID oral; 28-day a cycle until disease progresses.

DRUGGFH009

the RP2D of GFH009 defined in the preliminary phase 1b trial with the same schedule as in the phase Ib.

DRUGZanubrutinib

administered at 160mg BID oral; 28-day a cycle until disease progresses.


Locations(2)

Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute

Nanning, China

Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06375733


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