Combining Cue-101 and engineered T cells to treat HPV-positive head and neck cancer
Official title: Cue-101 and TCR-T cell Combinatorial Strategy for HPV+ Head and Neck Cancers
Funded at Yale University · NIH-11294142 · Data updated 2026-11-12
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 type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Yale University NIH-funded |
| Lab location | 1 site (New Haven, United States) |
| Project start | March 1, 2024 |
| Project end | February 28, 2029 |
| Funding year | 2026 |
| Award (this year) | $675,007 |
| NIH project number | 5R01CA278212-03 |
| Project ID | NIH-11294142 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
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Yale University
New Haven, United States Active
Researchers
- Principal investigator: Pai, Sara Isabel — Yale University
- Study coordinator: Pai, Sara Isabel
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.