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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: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Feb 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

  • 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
  • 29 Dec 2025 According to CEL-SCI Corporation media release, company plans to seek early approval based on early tumor response data which is expected by 2028.
  • 15 May 2025 According to CEL-SCI Corporation media release, company is in final stages. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI previously completed randomized controlled Phase 3 trial.

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