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E7 TCR-T Cells for HPV-Related Cancer

Phase 1 & 2
Waitlist Available
Led By Christian S Hinrichs, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if E7 TCR-T cell treatment can shrink or eliminate HPV-associated cancers to facilitate definitive therapy & increase survival.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to immune response such as fever, fatigue, inflammation around various organs; complications from cell infusion; and effects from aldesleukin like chills and nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC
Secondary study objectives
2-year and 5-year disease free survival (DFS)
Objective tumor response rate at 6-weeks after treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: E7 TCR-T cellsExperimental Treatment2 Interventions
Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1610

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
449 Previous Clinical Trials
65,790 Total Patients Enrolled
Christian HinrichsLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,986 Total Patients Enrolled
~10 spots leftby Oct 2026
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