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Phase 1, Phase 2RecruitingPriority 2 · High priorityNCT05934513

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

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is testing GFH009 for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

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

Drugs / treatments
GFH009
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT05934513

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: High

Plain-language summary

This Phase 1, Phase 2 trial is testing GFH009 for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

What's being tested

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

Drugs / treatments: GFH009

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 95 patients

Primary endpoint: Phase Ib: adverse events; Phase II: Objective Response Rate

Ages: 18 Years to 75 Years

Start date: 2023-09-06 | Est. completion: 2026-06-30

Locations

0 US sites · 1 total

Contact

Jin Li | jli@genfleet.com | +86 21 6882 1388

Sponsor: Genfleet Therapeutics (Shanghai) Inc. (INDUSTRY)

Tags

All T-cell lymphomas · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05934513

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.