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

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.

Conditions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• 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

2023-03-07

Primary Completion

2027-01-01

Completion

2027-01-01

FDA Drug

Yes

Countries

• United States

Study Locations