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A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin, Injection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naïve Adults With Resectable Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck

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Trial Profile

A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin, Injection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naïve Adults With Resectable Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2026

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At a glance

  • Drugs Buffy coat interleukins (Primary) ; Antineoplastics
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 17 Aug 2026 According to CEL-SCI Corporation media release, Peer-reviewed study in Oral Oncology identified prognostic biomarkers for selecting patients most likely to achieve substantial survival benefit from Multikine in upcoming Confirmatory Head & Neck Cancer Registration Study.
  • 13 Jul 2026 According to CEL-SCI Corporation media release, status changed from planning to not yet recruiting.
  • 19 Feb 2026 According to CEL-SCI Corporation media release, company starting enrollment in our U.S. FDA confirmatory Registration trial of Multikine in head and neck cancer and advancing Multikine globally in markets including Saudi Arabia. We plan to commence enrollment this summer in our confirmatory study of Multikine in head and neck cancer. Data from this study will be submitted as part of registration applications to allow commercialization and sale of Multikine in the U.S. and other key global market

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