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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Dec 2024

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At a glance

  • Drugs Tambiciclib (Primary)
  • Indications Peripheral T-cell lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors GenFleet Therapeutics; Sellas Life Sciences Group

Most Recent Events

  • 06 Feb 2024 According to GenFleet therapeutics media release, topline data from the Phase 1b/2 study of SLS009 expected by the end of the second quarter.
  • 11 Jan 2024 According to GenFleet therapeutics media release, the study is currently progressing into Phase II in close to 40 sites in China, following the completion of safety confirmation in Phase Ib.
  • 03 Jan 2024 According to a Sellas Life Sciences Group media release, Interim analysis is planned after 20-25 patients are enrolled and have undergone initial follow-up which is projected to occur by June 2024. The interim efficacy data will be discussed with regulatory agencies to decide on continuation of the trial as a pivotal registrational study that would enroll approximately 70-75 additional patients.

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