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

ConditionLarge B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • GFH009

    Drug

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

  • Zanubrutinib

    Drug

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

  • GFH009

    Drug

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

  • Zanubrutinib

    Drug

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

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: Phase 1b:GFH009 & ZanubrutinibExperimental treatment 2 interventions
Group B: Phase 2: GFH009 & ZanubrutinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase Ib: adverse events(AEs)

Incidence of DLT events, incidence and severity of AEs and serious adverse events (SAEs), Electrocardiogram changes

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
2

Phase II: ORR

ORR(Objective Response Rate) as assessed by the investigator according to the 2014 Lugano standards

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genfleet Therapeutics (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov
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