NCT02379520: HESTIA

HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers

Completed Phase 1 Last updated 13 April 2026

What this trial tests

Phase 1 trial testing HPV Specific T Cells in Human Papillomavirus-Related Carcinoma in 32 participants. Completed in 1 January 2026.

Timeline

1 September 2015

Primary endpoint
1 January 2026

1 January 2026

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 September 2015
Primary completion	1 January 2026
Estimated completion	1 January 2026
Sites	1 location across United States

Drugs / interventions tested

• HPV Specific T Cells
• Cytoxan — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Human Papillomavirus-Related Carcinoma — all drugs for Human Papillomavirus-Related Carcinoma →
• Human Papillomavirus Positive Oropharyngeal Carcinoma — all drugs for Human Papillomavirus Positive Oropharyngeal Carcinoma →
• Human Papillomavirus Positive Cervical Carcinoma — all drugs for Human Papillomavirus Positive Cervical Carcinoma →
• Human Papillomavirus Positive Anal Carcinoma — all drugs for Human Papillomavirus Positive Anal Carcinoma →

Sponsor

Baylor College of Medicine

Who can join

18 and older, any sex, with Human Papillomavirus-Related Carcinoma or Human Papillomavirus Positive Oropharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of patients with dose limiting toxicity (DLT)
  Time frame: 6 weeks
  DLT will be defined as any toxicity that is irreversible or life threatening, defined as the following, considered to be possibly, probably, or definitely related to the HPVST injection. 1. Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity. 2. Hematologic DLT is defined as any grade 4 hematologic toxicity.

Sponsor's own description

Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment.

This is a research study using special immune system cells called HPVST cells, a new experimental treatment.

Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood.

The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers.

If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC).
   Cohen EEW, Bell RB, Bifulco CB, Burtness B, et al · · 2019 · cited 528× · PMID 31307547 · DOI 10.1186/s40425-019-0662-5
2. Biological and clinical aspects of HPV-related cancers.
   Szymonowicz KA, Chen J. · · 2020 · cited 255× · PMID 33299640 · DOI 10.20892/j.issn.2095-3941.2020.0370
3. Therapeutic vaccines for high-risk HPV-associated diseases.
   Chabeda A, Yanez RJR, Lamprecht R, Meyers AE, et al · · 2018 · cited 148× · PMID 29277575 · DOI 10.1016/j.pvr.2017.12.006
4. Tumor Immunity and Immunotherapy for HPV-Related Cancers.
   Shamseddine AA, Burman B, Lee NY, Zamarin D, et al · · 2021 · cited 140× · PMID 33990345 · DOI 10.1158/2159-8290.cd-20-1760
5. Immunotherapy against cancer-related viruses.
   Tashiro H, Brenner MK. · · 2017 · cited 101× · PMID 28008927 · DOI 10.1038/cr.2016.153
6. Relationship between human papillomavirus and penile cancer-implications for prevention and treatment.
   Kidd LC, Chaing S, Chipollini J, Giuliano AR, et al · · 2017 · cited 82× · PMID 29184775 · DOI 10.21037/tau.2017.06.27
7. Tumor microenvironment and immunotherapy of oral cancer.
   Liu C, Wang M, Zhang H, Li C, et al · · 2022 · cited 78× · PMID 36209263 · DOI 10.1186/s40001-022-00835-4
8. The Key Differences between Human Papillomavirus-Positive and -Negative Head and Neck Cancers: Biological and Clinical Implications.
   Powell SF, Vu L, Spanos WC, Pyeon D. · · 2021 · cited 74× · PMID 34680354 · DOI 10.3390/cancers13205206