UnknownPhase 1

HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors

China12 participantsStarted 2023-04-13

Plain-language summary

The purpose of this protocol is to evaluate the feasibility and safety of HPV-T in HPV 16 positive recurrent or metastatic solid tumor patients.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
. Confirmed diagnosis of recurrent of metastatic solid tumor and at least one measurable lesion.
. HLA type is HLA-A0201.
. HPV 16 positive.
. Patients who failed or were intolerant to standard first-line treatment.
. Possess venous access for mononuclear cell collection or intravenous blood collection.
. Clinical performance status of ECOG is 0 or 1.
. Possess venous access for mononuclear cell collection or intravenous blood collection.

Exclusion criteria

. Pregnant or lactating women.
. History of severe immediate hypersensitivity reaction to HPV-T and any of the agents used in this study.
. Participants with a history of organ transplantation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events as assessed by CTCAE v5.0

Timeframe: Up to 24 months

Trial details

NCT IDNCT05895370

SponsorBGI, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-13

Contact for this trial

Guiling Li, Doctor

027-85873129 Lg16714@163.com

View on ClinicalTrials.gov More Solid Tumor trials