E7 TCR-T cells for Oropharyngeal Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Oropharyngeal Cancers+20 MoreE7 TCR-T cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Oropharyngeal Cancers
  • Anal Cancer
  • Human Papillomavirus-Related Penile Squamous Cell Carcinoma
  • Vulvar Cancer
  • Human Papillomavirus-Related Adenocarcinoma
  • Human Papillomavirus-Related Anal Squamous Cell Carcinoma
  • Metastatic Cancer
  • Human Papillomavirus-Related Malignancy
  • Throat Cancer
  • HPV-Associated Vaginal Adenocarcinoma
  • HPV-Related Adenosquamous Carcinoma
  • Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma
  • Penile Cancer
  • Cervical Cancer
  • Vaginal Cancer
  • Human Papillomavirus-Related Cervical Carcinoma
  • Human Papillomavirus-Related Squamous Cell Carcinoma
  • Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
  • Human Papillomavirus-Related Carcinoma
  • Human Papillomavirus-Related Endocervical Adenocarcinoma
  • HPV Positive Rectal Squamous Cell Carcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 5 years

5 years
Adverse Events
Five years
Tumor response

Trial Safety

Trial Design

1 Treatment Group

E7 TCR-T cells
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: E7 TCR-T cells · No Placebo Group · Phase 2

E7 TCR-T cells
Biological
Experimental Group · 1 Intervention: E7 TCR-T cells · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
376 Previous Clinical Trials
58,608 Total Patients Enrolled
1 Trials studying Oropharyngeal Cancers
600 Patients Enrolled for Oropharyngeal Cancers
Christian HinrichsLead Sponsor
2 Previous Clinical Trials
57 Total Patients Enrolled
Christian Hinrichs, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with metastatic or inoperable HPV-16+ cancer.
You have a tumor with the HPV16 genotype, as verified by testing in an accredited laboratory.
You must have the HLA-A*02:01 allele as determined by testing in a CLIA certified laboratory
You have a measurable illness as determined by RECIST Criteria Version 1.114.
You are 18 years or older.
Your Eastern Cooperative Oncology Group performance status is 0 or 1 at the screening phase.
You have either received prior first line standard therapy or have opted to forego such treatment.
Patients aged 18 years or older with three or fewer brain metastases that have been treated surgically and/or by stereotactic radiosurgery, who are fully recovered from surgery, and whose lesions have been clinically stable for one month prior to protocol treatment are eligible.
Women aged 55 or under and who have had a menstrual period in the last 12 months must provide a negative pregnancy test
You have been offered and refused conventional treatments for initial and secondary treatment, as outlined in Appendix VII.