E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 11, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
HPV-Associated Cervical CarcinomaHPV-Related CarcinomaHPV-Related MalignancyHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related AdenocarcinomaHPV-Related Adenosquamous CarcinomaHPV-Related Squamous Cell CarcinomaHPV-Related Anal Squamous Cell CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaHPV-Related Endocervical AdenocarcinomaCervical CancerOropharynx CancerAnal CancerVulvar CancerPenile CancerVaginal Cancer
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 will be administered every 8 hours as an inpatient for up to 3 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, New Brunswick

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

Sponsors
All Listed Sponsors
collaborator

Iovance Biotherapeutics, Inc.

INDUSTRY

lead

Christian Hinrichs

OTHER

NCT05639972 - E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers | Biotech Hunter | Biotech Hunter