A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Genfleet Therapeutics (Shanghai) Inc.1 site in 1 country95 target enrollmentSeptember 6, 2023

ConditionsRelapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

InterventionsGFH009

DrugsGFH009

Overview

Phase: Phase 1
Intervention: GFH009
Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Enrollment: 95
Locations: 1
Primary Endpoint: Phase Ib: adverse events
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 6, 2023

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 .
•Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
•Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.
•Eastern Cooperative Oncology Group performance status of ≤
•Adequate haematologic and organ function at screening.
•Life expectancy ≥ 12 week.
•Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and \< Grade 2 sensory neuropathy.

Exclusion Criteria

•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
•Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug; or undergone major surgery with 4 weeks; or received targeted therapy within 4 weeks or 5 half-lives whichever is shorter; or received immunotherapy.
•History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.
•Attend other clinical trial within 2 weeks prior to starting study drug.
•History of previous exposure to any other CDK9 inhibitor.
•Concurrent malignancy within 5 years prior to entry
•Uncontrolled pulmonary fibrosis, active lung diseases or interstitial lung disease.