Study on E7 T-Cell Therapy for Advanced HPV-Related Cancers

Sponsor: Christian Hinrichs

Sponsor score: 0

ClinicalTrials ID:NCT05639972

Provider View

This clinical trial is testing a new treatment using E7 TCR-T cells to help shrink or eliminate tumors in patients with advanced HPV-related cancers before they undergo standard treatments like chemotherapy or surgery.

Patient Parameters

Program Overview

The study aims to see if a single dose of E7 TCR-T cells can be safely given to patients with advanced HPV-related cancers to help reduce or eliminate tumors before they receive their main treatment, such as chemotherapy or surgery. The goal is to make the main treatment more effective and improve survival rates. Participants will have their T cells collected and modified in a lab to create E7 TCR-T cells, which will then be infused back into their body. The study will monitor how well the tumors respond and the safety of the treatment.

Description

This study is testing a new treatment called E7 TCR-T cell therapy for patients with advanced HPV-related cancers. Participants must have a specific type of HPV-positive cancer and a genetic marker called HLA-A*02:01. The process involves collecting the patient's T cells, modifying them in a lab to target cancer cells, and then infusing them back into the patient. Before the infusion, patients will receive a treatment to prepare their body, followed by a single dose of E7 TCR-T cells and a supportive medication called aldesleukin. The study will check the tumor's response to the treatment and monitor the patient's health. After six weeks, patients will return to their regular cancer treatment team for further therapy. The study will also track the patient's health over two and five years to see how well they do without the cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a specific type of HPV-related cancer.
  • The cancer must be HPV16 positive and have a specific genetic marker (HLA-A*02:01).
  • Have measurable cancer according to standard criteria.
  • Be over 18 years old.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Women under 55 must have a negative pregnancy test unless they have had certain surgeries.
  • Agree to use effective birth control during the study and for four months after treatment.
  • Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Have adequate organ and blood function as determined by specific tests.
  • Be able to understand and sign a consent form.
  • Agree to participate in related studies for long-term follow-up and biospecimen collection.

Exclusion Criteria

  • Have received prior treatment for the cancer being studied.
  • Currently taking another investigational drug.
  • Have severe allergies to similar treatments.
  • Have uncontrolled illnesses like infections or heart problems.
  • Have certain genetic mutations or resistance to the treatment.
  • Have a heart function of 45% or lower.
  • Have low oxygen levels in the blood.
  • Be breastfeeding.
  • Have a weakened immune system or be on immunosuppressive drugs.
  • Have severe autoimmune diseases.
  • Have had another cancer that could interfere with the study.
  • Have received a live vaccine within 30 days before the study.
  • The study doctor determines participation is not safe or in the patient's best interest.

Locations

FACILITYZIPCITYSTATE
Rutgers Cancer Institute of New Jersey08901New BrunswickNew Jersey
RWJBarnabas Health - Robert Wood Johnson University Hospital08901New BrunswickNew Jersey

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.