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
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 .
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
Single group
GFH009
Drugpatients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion
Phase Ib: adverse events
Incidence of intolerable toxic events, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Phase II: Objective Response Rate
ORR(Objective Response Rate)
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