Combining Cue-101 and engineered T cells to treat HPV-positive head and neck cancer

Cue-101 and TCR-T cell Combinatorial Strategy for HPV+ Head and Neck Cancers

NIH-funded research Yale University · NIH-11294142

Doctors are combining Cue-101 with specially engineered T cells to help people with HPV16-positive head and neck cancer by improving tumor targeting while using lower cell doses.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionYale University NIH-funded
Lab location1 site (New Haven, United States)
Project IDNIH-11294142 on NIH RePORTER

What this research studies

You would get T cells taken from your own blood that are genetically engineered to recognize the HPV16 E7 protein found on cancer cells, and those cells would be given back at a lower dose alongside a drug called Cue-101 intended to help the T cells get into the tumor and stick around. This approach aims to reduce the high-dose cell and cytokine treatments that can cause toxicity while boosting anti-tumor activity. Eligibility depends on having an HPV16-positive tumor and the HLA-A*0201 type needed for the engineered T cells to recognize the cancer. The team builds on earlier first-in-human TCR-T work and will perform proof-of-concept experiments to see if the combo improves recruitment and persistence of the transferred cells.

Who could benefit from this research

Good fit: Ideal candidates are people with HPV16-positive head and neck cancer who express HLA-A*0201 and who are eligible for adoptive T cell therapy.

Not a fit: Patients whose tumors are not driven by HPV16 or who do not carry HLA-A*0201 would not be expected to benefit or be eligible for this approach.

Why it matters

Potential benefit: If successful, the combination could improve tumor control while lowering treatment-related side effects by allowing effective responses with fewer transferred T cells.

How similar studies have performed: Prior first-in-human trials of HPV16 E7-directed TCR-T cells showed safety and signs of tumor response, but combining those cells with Cue-101 to enhance tumor recruitment is a newer strategy.

Where this research is happening

New Haven, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.