Health Trials

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

ConditionsCervical CancerThroat CancerOropharynx CancerAnal CancerVulva CancerVaginal CancerPenile CancerMetastatic CancerHPV-Related MalignancyHPV-Related CarcinomaHPV-Related Cervical CarcinomaHPV-Related Squamous Cell CarcinomaHPV-Related AdenocarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Associated Vaginal AdenocarcinomaHPV-Related Adenosquamous CarcinomaHPV-Related Endocervical AdenocarcinomaHPV-Related Anal Squamous Cell CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaHPV Positive Rectal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristian Hinrichs

About this trial

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.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer.

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

HLA-A*02:01 allele as 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 as assessed by RECIST Criteria Version 1.1.

Disqualifiers

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.

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

History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.

Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or

Trial design

Treatments tested in this trial

  • E7 TCR-T cells
  • Aldesleukin

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

3
National Institutes of Health Clinical Center20892, BethesdaMaryland, United States
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

National Cancer Institute (NCI)

Collaborator

Iovance Biotherapeutics, Inc.

Collaborator

Source ClinicalTrials.gov