E7 TCR-T Cells for HPV-Related Cancer

Recruiting at 1 trial location

Overseen by Christian S Hinrichs, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christian S Hinrichs, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

Adults over 18 with advanced HPV-related cancers (like cervical, anal, and oropharyngeal cancer) that have the HPV16 genotype. They must be in good health with proper organ function and not HIV or hepatitis positive. Women of childbearing age should use contraception and cannot be pregnant.

Inclusion Criteria

I am not pregnant or have had surgery to remove my ovaries or uterus.

I do not have HIV, hepatitis B, or active hepatitis C.

I am fully active or restricted in physically strenuous activity but can do light work.

Treatment Details

Interventions

• Aldesleukin (Cytokine)
• Conditioning (Other)
• E7 TCR-T cells (CAR T-cell Therapy)

Trial Overview The trial is testing E7 TCR-T cells as a pre-treatment to shrink tumors before main treatment like surgery or chemoradiation. It involves taking patients' T cells, modifying them to fight cancer, then giving them back along with aldesleukin to boost the immune system.

Participant Groups

Group I: E7 TCR-T cells Experimental Treatment 2 Interventions

Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Christian Hinrichs

Lead Sponsor

Trials

3

Recruited

70+

Iovance Biotherapeutics, Inc.

Industry Sponsor

Trials

26

Recruited

1,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+