RecruitingPhase 2NCT05686226

E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers

A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers


Sponsor

Christian Hinrichs

Enrollment

20 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized immune cell therapy (called E7 TCR-T cell therapy) for people with cancers caused by a specific strain of the human papillomavirus (HPV-16), including cervical, head and neck, anal, and other HPV-related cancers that have spread or returned after standard treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed HPV-16 positive cancer that has spread or is recurring - Your tumor has been confirmed to carry the HPV-16 strain - You carry a specific immune system marker called HLA-A*02:01 - Your cancer has measurable disease on scans - You have received or declined standard first-line treatment - You are in good physical health (ECOG 0–1) **You may NOT be eligible if...** - Your tumor does not carry HPV-16 - You do not have the HLA-A*02:01 genetic marker - You have more than 3 brain metastases, or brain metastases that are not stable - You are pregnant or unwilling to use contraception - You have serious autoimmune disease or are on immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALE7 TCR-T cells

Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. E7 TCR-T cells will be administered as a single intravenous infusion.

DRUGAldesleukin

Within 24 hours after E7 TCR-T cell infusion, aldesleukin 720,000 IU/kg IV every eight hours will be administered for up to six doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion.


Locations(3)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05686226


Related Trials