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

ConditionsCervical 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

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

E7 TCR-T cells
Biological/Vaccine
Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. E7 TCR-T cells will be administered as a single intravenous infusion.
Aldesleukin
Drug
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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: E7 TCR-T cellsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Tumor response

Objective tumor response as measured by RECIST

Time frame

5 years

Secondary outcomes

Adverse Events

Adverse events as measured by CTCAE

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christian Hinrichs

Lead sponsor

Rutgers, The State University of New Jersey

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Iovance Biotherapeutics, Inc.