Human Papillomavirus-Related CarcinomaPhase 1HESTIANCT02379520
HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA
A Phase 1 study testing HPV Specific T Cells, Cytoxan and Fludarabine in people with Human Papillomavirus-Related Carcinoma and Human Papillomavirus Positive Oropharyngeal Carcinoma, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma
- What is being tested?
- HPV Specific T Cells, Cytoxan and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PROCUREMENT
- Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample
- Cancer is:
- recurrent or persistent after standard therapy
- OR patient is unable to receive standard therapy
- Karnofsky score ≥ 50%
Show all 22Show fewer
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
- TREATMENT
- Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample
- Cancer is:
- recurrent or persistent after standard therapy
- OR patient is unable to receive standard therapy
- Life expectancy ≥ 6 weeks.
- Age ≥ 18 years.
- Karnofsky score ≥ 50%
- Bilirubin < 3 × upper limit of normal (ULN), AST < 5 × ULN, Hgb ≥ 7.0 g/dL
- Pulse oximetry of > 90% on room air.
- GFR > 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent.
- ANC > 1.0/μL
- Platelets > 75,000/μL
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
Who cannot join
- PROCUREMENT
- 1. Known HIV positivity.
- TREATMENT
- Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.
- Severe intercurrent infection.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers
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.
Read more
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.
Read the detailed description
HPV is found in the cancer cells of more than half the patients with certain types of cancer, suggesting that it may play a role in causing the cancer. The virus makes proteins in the tumor cells that should allow the diseased cells to be recognized and killed by a part of the body's own immune system called T cells. Unfortunately, tumors are able to avoid being killed by making molecules that turn off these T cells. So, the cancer cells infected by HPV are able to hide from the body's immune system and escape destruction.
The investigators have previously studied cancers caused by a different virus, called Epstein-Barr virus (EBV). These EBV-cancers are like HPV-cancers, since they turn off the T cells that would otherwise destroy them, and so can keep growing. They investigators have found, however, that if they removed the T cells from the blood of patients with EBV-cancers and grew them outside the body, they could increase the number and the activity of T cells directed against the tumors. When these T cells were given back to the patients, the T cells eliminated the cancers in over half the recipients. Investigators also found that they could engineer the T cells to be even more active against the EBV-cancer cells by making them resist an inhibitory chemical called TGF-beta, which is produced by these cancer cells.
Investigators will collect up to 390 mL of blood. Then they will use this blood to grow T cells. First they will grow them in a special type of cell called a dendritic cell, which stimulates the T cells. These dendritic cells will then be loaded with bits of proteins from the HPV virus called E6 and E7. These dendritic cells will be used to stimulate T cells. This stimulation trains the T cells to kill cells with the HPV proteins E6 and E7 on their surface. Next, the investigators will grow these HPV-specific T cells by more stimulation with dendritic cells and HPV proteins, and, when needed, a special type of cell called K562. These K562 cells were treated with radiation so they cannot grow.
To make these T cells resistant to the TGF-beta released by the tumor, investigators will put a new gene in them in the laboratory called a mutant TGF-beta receptor. In cells with this new gene, TGF-beta released by the tumor cells will not be able to bind to the mutant TGF-beta receptor on the T cell. Investigators hope this will improve the chances that after the T cells are injected they will be able to keep working and kill the tumor cells. This gene is added to the cells using a mouse retrovirus that has been changed to stop it from causing infections. Retroviruses enter the cell's DNA (genetic material) to make permanent changes to the cell. After making these cells, they will be frozen.
For treatment, the cells will be thawed and injected in a vein over 1 to 10 minutes. Initially, one dose of T cells will be given (which is considered day 0).
If, after the 1st infusion, there is a reduction in the size of the subject's cancer (or no increase) on CT or MRI scans as assessed by a radiologist, the subject can receive additional doses if it would be to his/her benefit, if s/he would like to receive more doses, and if there is enough product remaining to give any additional injections (at the same or a lower dose).
If treatment with HPVST cells alone proves safe, additional group of patients (Group B) will receive HPVST cells with nivolumab in lymphodepleted environment. One dose of the drug nivolumab is given one day before the HPVST cells are infused and then every 2 weeks for a total of four doses of nivolumab. Lymphodepletion will be given daily starting day -4 prior to administration of HPVSTs.
This is a dose escalation study. The dose the patient will get will depend on how many participants get the agent beforehand and how they react.
Investigators will follow the patient during and after the injections at predetermined time points which may require blood draws and other examinations.
- Conditions
- Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma, Human Papillomavirus Positive Anal Carcinoma, Human Papillomavirus Positive Vulvar Carcinoma, Human Papillomavirus Positive Penile Carcinoma
- Being tested
- HPV Specific T Cells, Cytoxan, Fludarabine, Nivolumab
- Keywords
- recurrent cancer, refractory cancer, virus specific T-cells, gene therapy, HPV
- Medical subject headings
- Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Specific T CellsGenetic
Also called HPVSTs
Dose escalation study with 5 dose levels: DL1-1×10^7 cells/m2, DL2-3×10^7 cells/m2, and DL3-1×10^8 cells/m2, DL4- 2 to 3×10^8 cells/m2, DL5- 0.8 to 1×10^9 cells/m2
Group A -HPVST cells Group B -lymphodepletion \& nivolumab \& HPVST cells.
First, treatment in Group A will be completed for DL1 and DL2. Only if DL2 in Group A proves safe, Group B will be treated on DL2, DL3, DL4, and DL5.
Group A will be treated at DL3, DL4, and DL5 only if there is excessive toxicity in cohorts treated with lymphodepletion.
HPVSTs will be given by IV injection over 1-10 minutes through a peripheral or a central line on day 0.
If patients have clinical benefit (as determined by symptoms, physical exam or radiological studies) \& no significant toxicities, they may get up to 5 repeat infusions (for max total of 6 infusions) of HPVSTs at or below the same dose level.
CytoxanDrug
Also called cyclophosphamide
500mg/m^2/day x 3 days (on days -4, -3 and -2)
FludarabineDrug
Also called Fludara
30mg/m^2/day x 3 days (on days -4, -3, and -2)
NivolumabBiological
Also called Opdivo
240mg every 2 weeks (+/- 3 days) starting on day -1
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | HPV Specific T Cells Receives: Genetic: HPV Specific T Cells |
| Group B | Experimental | HPV Specific T Cells plus lymphodepletion (Cytoxan and Fludarabine) and nivolumab Receives: Genetic: HPV Specific T Cells; Drug: Cytoxan; Drug: Fludarabine; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity (DLT)
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.
- Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity.
- Hematologic DLT is defined as any grade 4 hematologic toxicity.
Measured: 6 weeks
Secondary outcomes (1)
Overall response rate
To measure anti-tumor effects of HPV-specific T lymphocytes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2026
- Study completionJan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Carlos Ramos, MD, Principal investigator, The Methodist Hospital Research InstituteHelen Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379520
- Sponsor's protocol ID
- H-36021 HESTIA
- Acronym
- HESTIA
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2015
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers
- ClinicalTrials.gov ID
- NCT02379520
- Acronym / sponsor ID
- HESTIA / H-36021 HESTIA
- Conditions
- Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma, Human Papillomavirus Positive Anal Carcinoma, Human Papillomavirus Positive Vulvar Carcinoma, Human Papillomavirus Positive Penile Carcinoma
- Keywords
- recurrent cancer, refractory cancer, virus specific T-cells, gene therapy, HPV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Sep 2015
- Primary completion
- Jan 2026 (actual)
- Study completion
- Jan 2026 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HPV is found in the cancer cells of more than half the patients with certain types of cancer, suggesting that it may play a role in causing the cancer. The virus makes proteins in the tumor cells that should allow the diseased cells to be recognized and killed by a part of the body's own immune system called T cells. Unfortunately, tumors are able to avoid being killed by making molecules that turn off these T cells. So, the cancer cells infected by HPV are able to hide from the body's immune system and escape destruction.
The investigators have previously studied cancers caused by a different virus, called Epstein-Barr virus (EBV). These EBV-cancers are like HPV-cancers, since they turn off the T cells that would otherwise destroy them, and so can keep growing. They investigators have found, however, that if they removed the T cells from the blood of patients with EBV-cancers and grew them outside the body, they could increase the number and the activity of T cells directed against the tumors. When these T cells were given back to the patients, the T cells eliminated the cancers in over half the recipients. Investigators also found that they could engineer the T cells to be even more active against the EBV-cancer cells by making them resist an inhibitory chemical called TGF-beta, which is produced by these cancer cells.
Investigators will collect up to 390 mL of blood. Then they will use this blood to grow T cells. First they will grow them in a special type of cell called a dendritic cell, which stimulates the T cells. These dendritic cells will then be loaded with bits of proteins from the HPV virus called E6 and E7. These dendritic cells will be used to stimulate T cells. This stimulation trains the T cells to kill cells with the HPV proteins E6 and E7 on their surface. Next, the investigators will grow these HPV-specific T cells by more stimulation with dendritic cells and HPV proteins, and, when needed, a special type of cell called K562. These K562 cells were treated with radiation so they cannot grow.
To make these T cells resistant to the TGF-beta released by the tumor, investigators will put a new gene in them in the laboratory called a mutant TGF-beta receptor. In cells with this new gene, TGF-beta released by the tumor cells will not be able to bind to the mutant TGF-beta receptor on the T cell. Investigators hope this will improve the chances that after the T cells are injected they will be able to keep working and kill the tumor cells. This gene is added to the cells using a mouse retrovirus that has been changed to stop it from causing infections. Retroviruses enter the cell's DNA (genetic material) to make permanent changes to the cell. After making these cells, they will be frozen.
For treatment, the cells will be thawed and injected in a vein over 1 to 10 minutes. Initially, one dose of T cells will be given (which is considered day 0).
If, after the 1st infusion, there is a reduction in the size of the subject's cancer (or no increase) on CT or MRI scans as assessed by a radiologist, the subject can receive additional doses if it would be to his/her benefit, if s/he would like to receive more doses, and if there is enough product remaining to give any additional injections (at the same or a lower dose).
If treatment with HPVST cells alone proves safe, additional group of patients (Group B) will receive HPVST cells with nivolumab in lymphodepleted environment. One dose of the drug nivolumab is given one day before the HPVST cells are infused and then every 2 weeks for a total of four doses of nivolumab. Lymphodepletion will be given daily starting day -4 prior to administration of HPVSTs.
This is a dose escalation study. The dose the patient will get will depend on how many participants get the agent beforehand and how they react.
Investigators will follow the patient during and after the injections at predetermined time points which may require blood draws and other examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Genetic: HPV Specific T CellsHPV Specific T Cells |
| Group B | Experimental | Genetic: HPV Specific T Cells, Drug: Cytoxan, Drug: Fludarabine, Biological: NivolumabHPV Specific T Cells plus lymphodepletion (Cytoxan and Fludarabine) and nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- PROCUREMENT
- Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample
- Cancer is:
- Karnofsky score ≥ 50%
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Key exclusion criteria (6 listed)
- PROCUREMENT
- 1. Known HIV positivity.
- TREATMENT
- Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.
- Severe intercurrent infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Specific T CellsAlso: HPVSTsDose escalation study with 5 dose levels: DL1-1×10^7 cells/m2, DL2-3×10^7 cells/m2, and DL3-1×10^8 cells/m2, DL4- 2 to 3×10^8 cells/m2, DL5- 0.8 to 1×10^9 cells/m2 Group A -HPVST cells Group B -lymphodepletion \& nivolumab \& HPVST cells. First, treatment in Group A will be completed for DL1 and DL2. Only if DL2 in Group A proves safe, Group B will be treated on DL2, DL3, DL4, and DL5. Group A will be treated at DL3, DL4, and DL5 only if there is excessive toxicity in cohorts treated with lymphodepletion. HPVSTs will be given by IV injection over 1-10 minutes through a peripheral or a central line on day 0. If patients have clinical benefit (as determined by symptoms, physical exam or radiological studies) \& no significant toxicities, they may get up to 5 repeat infusions (for max total of 6 infusions) of HPVSTs at or below the same dose level. | Genetic | Group A, Group B |
| CytoxanAlso: cyclophosphamide500mg/m^2/day x 3 days (on days -4, -3 and -2) | Drug | Group B |
| FludarabineAlso: Fludara30mg/m^2/day x 3 days (on days -4, -3, and -2) | Drug | Group B |
| NivolumabAlso: Opdivo240mg every 2 weeks (+/- 3 days) starting on day -1 | Biological | Group B |
Primary outcome
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.
1 secondary outcome
Overall response rate
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Ramos, MD principal investigator
The Methodist Hospital Research Institute
Helen Heslop, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPV Specific T Cells, Cytoxan and Fludarabine in people with Human Papillomavirus-Related Carcinoma and Human Papillomavirus Positive Oropharyngeal Carcinoma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicity (DLT) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.