NCT06375733

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Large B-cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-04-19
• Last updated: 2025-08-12

Locations

2 sites across 1 country: China