RecruitingPhase 1Phase 2NCT05934513

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

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)


Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Enrollment

95 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called GFH009 in people with peripheral T-cell lymphoma (PTCL), a type of aggressive blood cancer, that has returned or stopped responding to treatment. The study is looking at whether GFH009 is safe and effective for this group. **You may be eligible if...** - You are aged 18–75 - You have been confirmed to have relapsed or refractory peripheral T-cell lymphoma - You have received and failed at least 2 but no more than 5 prior treatments - You have at least one measurable tumor - You are in reasonable health (ECOG performance status 0–2) - Tumor tissue is available for testing - Your blood counts and organ function meet required levels - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have not previously received treatment for PTCL - You have had more than 5 prior lines of therapy - Your organ function does not meet study requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGFH009

patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion


Locations(1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

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NCT05934513