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

Summary

The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.

This study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.

Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.

Conditions

• HPV-Associated Cervical Carcinoma
• HPV-Related Carcinoma
• HPV-Related Malignancy
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• HPV-Related Adenocarcinoma
• HPV-Related Adenosquamous Carcinoma
• HPV-Related Squamous Cell Carcinoma
• HPV-Related Anal Squamous Cell Carcinoma
• HPV-Related Penile Squamous Cell Carcinoma
• HPV-Related Vulvar Squamous Cell Carcinoma
• HPV-Related Endocervical Adenocarcinoma
• Cervical Cancer
• Oropharynx Cancer
• Anal Cancer
• Vulvar Cancer
• Penile Cancer
• Vaginal 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.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.

  collaborator INDUSTRY

• Christian Hinrichs

  lead OTHER

Principal Investigators

• Christian S Hinrichs, MD · Rutgers Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-11

Primary Completion

2026-10-01

Completion

2026-10-01

FDA Drug

Yes

Countries

• United States

Study Locations