NCT05686226

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Christian Hinrichs · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will determine the tumor response rate for the treatment of HPV-associated cancers with E7 TCR-T cells. E7 TCR-T cells are autologous gene-engineered T cells that target HPV16 E7 through a T cell receptor (TCR). E7 is an HPV oncoprotein that is present in HPV-associated cancers. Participants must have the HLA-A\*02:01 allele, which is required for tumor targeting by the E7 TCR. Treatment consists of a conditioning regimen (cyclophosphamide and fludarabine), a single infusion of E7 TCR-T cells, and adjuvant aldesleukin. Tumor response rate and response duration will be determined. Safety data will also be collected.

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

Type	Name	Description
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.

Timeline

• Start date: 2023-03-07
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-01-17
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study