Health Trials

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

ConditionsHPV-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
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristian Hinrichs

About 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.

Eligibility criteria

Qualifiers

Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.

Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.

HLA-A*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis.

Measurable disease per RECIST Criteria Version 1.1 or PERCIST.

Disqualifiers

Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.

Current treatment with another investigational agent.

History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.

Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.

Trial design

Treatments tested in this trial

  • E7 TCR-T cells
  • Aldesleukin

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

2
Rutgers Cancer Institute08901, New BrunswickNew Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital08901, New BrunswickNew Jersey, United States

Sponsors and collaborators

Christian Hinrichs

Lead sponsor

Rutgers, The State University of New Jersey

Sponsor institution

Iovance Biotherapeutics, Inc.

Collaborator

Source ClinicalTrials.gov