Study on Three Schedules of CUE-101 Before Surgery or Chemoradiation in Patients with Advanced HPV16-Positive Throat Cancer

Inclusion Criteria

• Diagnosed with squamous-cell carcinoma of the throat or a neck mass suspected to be throat cancer.
• Cancer stage I-III, except for specific early stages.
• Eligible for standard treatment, either surgery followed by additional therapy or chemoradiation.
• Positive for HLA-A*0201 genetic marker.
• Tumors must test positive for HPV16 and show specific protein expression.
• Provide a tumor tissue sample for eligibility.
• At least 18 years old.
• Good overall health with a performance status of 0 or 1.
• Normal blood and organ function, including:
  • Platelets ≥ 100,000/mcl
  • Hemoglobin ≥ 9.0 g/dL
  • Neutrophil count ≥ 1,500/mcl
  • Liver enzymes and bilirubin within specified limits
  • Creatinine < 1.5 mg/dL or clearance >30 mL/min
• Agree to use effective contraception during the study.
• Able to understand and sign informed consent.

Exclusion Criteria

• Previous bone marrow, stem-cell, or organ transplant.
• Cancer that has spread to distant parts of the body.
• Prior radiation or cancer treatment before the study drug.
• Use of high-dose steroids or immune suppressive drugs recently.
• Significant heart disease or recent heart events.
• Lung issues requiring oxygen.
• Serious digestive disorders or recent bleeding.
• Active infections needing treatment recently.
• History of hepatitis B or C, unless treated and in remission.
• Another cancer not in remission for over 2 years, with some exceptions.
• Previous radiation to the head and neck.
• Major surgery recently.
• Serious medical conditions affecting treatment.
• Allergies to study drug components.
• Recent live virus vaccination.
• Substance abuse issues recently.
• Pregnant or breastfeeding women.