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A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy

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Trial Profile

A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs FK-PC101 (Primary)
  • Indications Prostate cancer
  • Focus Therapeutic Use
  • Sponsors CellVax Therapeutics

Most Recent Events

  • 11 Oct 2024 Status changed to recruiting.
  • 29 Jan 2024 According to CellVax Therapeutics media release, Theragent will be responsible for end-to-end manufacturing, release, and disposition of all clinical material out of its purpose-built, state-of-the-art CGMP cell therapy manufacturing facility in Arcadia, CA.
  • 29 Jan 2024 According to CellVax Therapeutics media release, the company has received clearance of IND by the U.S. Food and Drug Administration (FDA) for FK-PC101 phase II study. The first patient treatments expected in Q2 2024. This trial is being conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), with Scott Eggener, MD as Principal Investigator. Participants sourced from 21 pre-selected U.S. sites.

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