NCT05686226 - E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 7, 2023

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2027

Conditions

Cervical CancerThroat CancerOropharynx CancerAnal CancerVulva CancerVaginal CancerPenile CancerMetastatic CancerHPV-Related MalignancyHPV-Related CarcinomaHPV-Related Cervical CarcinomaHPV-Related Squamous Cell CarcinomaHPV-Related AdenocarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Associated Vaginal AdenocarcinomaHPV-Related Adenosquamous CarcinomaHPV-Related Endocervical AdenocarcinomaHPV-Related Anal Squamous Cell CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaHPV Positive Rectal Squamous Cell Carcinoma

Interventions

BIOLOGICAL

E7 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.

DRUG

Aldesleukin

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.

Trial Locations (2)

08901

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick