Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether a patient’s T cells, genetically equipped with a receptor that recognises the HPV E7 protein, can find and kill HPV-associated cancer cells after chemotherapy conditioning. Aldesleukin, an immune-growth signal, is given to help the transferred cells expand or remain active.
The idea is that directing immune cells at a viral protein found in the cancer could produce tumour shrinkage in metastatic HPV-associated cancers, where standard treatment may not control the disease. The trial measures tumour response, rather than directly comparing survival or time before the cancer grows with another treatment.
Worth knowing: This is a small, non-randomised phase 2 trial of 20 people, so it has no comparison group and is designed to assess response rather than establish whether the treatment improves survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05686226 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 20 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Christian Hinrichs |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological E7 TCR-T cells
- Drug Aldesleukin
What it is measuring
Tumor response
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
- Not yet treated
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.
1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer.
2. Tumor and/or blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
3. HLA-A*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis.
4. Measurable disease as assessed by RECIST Criteria Version 1.1.
5. Age ≥ 18 years.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.
7. Must have received prior first line standard therapy or have declined standard therapy.
8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).
9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.
10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 3 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05686226, registered by Christian Hinrichs on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.