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

NCT06375733 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-08-12

No results posted yet for this study

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)

Conditions

Interventions

DRUG

GFH009

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

DRUG

Zanubrutinib

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

DRUG

GFH009

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

DRUG

Zanubrutinib

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

Sponsors & Collaborators

  • Genfleet Therapeutics (Shanghai) Inc.

    lead INDUSTRY

Principal Investigators

  • Keshu Zhou, MD · Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375733 on ClinicalTrials.gov