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# FDA Lifts Clinical Hold on CEL-SCI Phase 3 Study
- URL: https://www.fdaweb.com/fda-lifts-clinical-hold-on-cel-sci-phase-3-study/
- Published: 2017-08-14T12:00:00.000Z
- Updated: 2026-09-14T22:40:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139372

FDA has lifted a clinical hold against CEL-SCI Corp. and its Phase 3 cancer study with Multikine (leukocyte interleukin, injection), allowing all clinical trial activities under the company’s IND to resume. In June, CEL-SCI responded to FDA about the clinical hold on the Phase 3 head and neck cancer study. The response addressed the study’s investigator brochure and a “Dear Investigator” letter, which were revised based on earlier FDA comments.

  
The hold was ordered 9/2016, but it allowed patients currently receiving study treatments to continue to receive treatment, and patients already enrolled in the study to continue to be followed,” the company said at the time. The study currently has about 926 enrolled head and neck cancer patients with advanced disease who are treatment-naïve. 

Multikine is being developed as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response. Data from Phase 1 and Phase 2 clinical trials suggest that Multikine may simulate a healthy person’s immune system, enabling it to use the body’s own anti-tumor immune response, according to CEL-SCI.

  
The Phase 3 study’s primary endpoint is a 10% increase in overall survival for patients treated with the Multikine treatment regimen plus standard of care (SOC) versus those who receive SOC only, according to the company. “The determination if the study’s primary end point has been met will occur when there are a total of 298 deaths in those two groups,” it says. “Current SOC for this indication is surgery, followed by radiation therapy alone or followed by concurrent radio-chemotherapy.”