A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
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 efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma

Eligibility criteria

Qualifiers

Male or female ≥ 18 years and ≤ 75 years.

Written informed consent must be obtained prior to any screening procedures.

Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.

Must have received and failed at least 2 but no more than 5 prior lines of therapies .

Disqualifiers

Diagnosis of Cutaneous T-cell lymphoma .

Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.

Patients with severe hemophagocytic syndrome at screening.

Presence of uncontrolled third space effusion

Trial design

Treatments tested in this trial

  • GFH009

Treatment groups

95 Participants
are divided into 1 treatment group