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Engineered immune cells take on HPV cancers in early trial

NCT ID NCT02379520

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new experimental treatment called HPVST cells in 32 people with HPV-related cancers that had returned or not responded to standard care. The cells are grown from the patient's own blood and trained to attack HPV-infected cancer cells. The goal was to find a safe dose and see if the cells can survive and fight the tumor. Some participants also received the drug nivolumab to boost the immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HPV-specific T cells (HPVSTs) with or without nivolumab
What this could lead to
If successful, this could point toward a new treatment option for patients with HPV-related cancers that have not responded to standard therapy.
What could go wrong
This is an early Phase 1 trial with only 32 participants, so results may not apply broadly. Side effects from the cell infusion or combination with nivolumab could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Sep 2015

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: PROCUREMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is: * recurrent or persistent after standard therapy * OR patient is unable to receive standard therapy 3. Karnofsky score ≥ 50% 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent TREATMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is: * recurrent or persistent after standard therapy * OR patient is unable to receive standard therapy 3. Life expectancy ≥ 6 weeks. 4. Age ≥ 18 years. 5. Karnofsky score ≥ 50% 6. Bilirubin \< 3 × upper limit of normal (ULN), AST \< 5 × ULN, Hgb ≥ 7.0 g/dL 7. Pulse oximetry of \> 90% on room air. 8. GFR \> 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent. 9. ANC \> 1.0/μL 10. Platelets \> 75,000/μL 11. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent 12. 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. Exclusion Criteria: PROCUREMENT 1\. Known HIV positivity. TREATMENT 1. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks. 2. Severe intercurrent infection. 3. Pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.