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RECRUITING
NCT06375733
PHASE1/PHASE2

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

Sponsor: Genfleet Therapeutics (Shanghai) Inc.

View on ClinicalTrials.gov

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)

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2024-03-20

Completion Date

2026-12-31

Last Updated

2025-08-12

Healthy Volunteers

No

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.

Locations (2)

Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute

Nanning, China

Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital

Zhengzhou, China