E7 TCR-T Cell Immunotherapy for HPV-Related Cancers

Sponsor: Christian Hinrichs

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05686226

Provider View

This phase II clinical trial is testing a new immunotherapy using E7 TCR-T cells to treat cancers linked to the human papillomavirus (HPV), such as cervical and throat cancer. Participants will receive a special treatment plan, including E7 TCR-T cells, to see if it helps reduce their cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment for cancers associated with HPV, like cervical, throat, and other related cancers. The treatment uses E7 TCR-T cells, which are specially engineered to target and attack cancer cells with the HPV16 E7 protein. Participants will receive a combination of treatments, including a conditioning regimen, E7 TCR-T cells, and a supportive drug called aldesleukin. The study will measure how well the treatment works in shrinking tumors and how long the effects last, while also monitoring safety.

Description

The trial aims to see how well E7 TCR-T cells can shrink tumors in HPV-related cancers. These cells are modified from a patient's own immune cells to specifically target the HPV16 E7 protein found in these cancers. To be eligible, participants need to have a specific genetic marker (HLA-A*02:01) that allows the treatment to work effectively. The treatment involves a preparatory regimen with chemotherapy drugs (cyclophosphamide and fludarabine), followed by an infusion of the E7 TCR-T cells, and then a drug called aldesleukin to support the treatment. Researchers will track the tumor response and how long the effects last, while also collecting safety data.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic or recurring HPV-16 positive cancer.
  • Cancer must have the HPV16 genotype confirmed by a certified lab test.
  • Must have the HLA-A*02:01 genetic marker confirmed by a certified lab test.
  • Have measurable cancer as per standard criteria.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Must have received or declined standard first-line therapy.
  • Must have declined standard second-line therapy options.
  • Can have up to three brain metastases that are stable after treatment.
  • Women under 55 or who have had a period in the last year must have a negative pregnancy test.
  • Must agree to use effective birth control during and for four months after treatment.
  • Must test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Must have adequate organ and marrow function as per specific blood test results.
  • Must have completed any prior systemic therapy at least four weeks before receiving E7 TCR cells.
  • Must be able to understand and sign informed consent.
  • Must agree to participate in related long-term follow-up and biospecimen collection studies.

Exclusion Criteria

  • Have uncontrolled illnesses like active infections or heart problems that would interfere with the study.
  • Have severe allergies to similar treatments used in the study.
  • Have a history of heart procedures unless cleared by a stress test.
  • Have a heart function of 45% or lower.
  • Have a low oxygen level in the blood unless it improves.
  • Have genetic resistance to the treatment.
  • Be breastfeeding, as the treatment may affect the baby.
  • Have a weakened immune system, such as from HIV or other conditions.
  • Be on immunosuppressive drugs unless specified otherwise.
  • Have severe autoimmune diseases like Crohn's disease or lupus.
  • Have other cancers that could interfere with the study, except for certain low-risk cancers.
  • Have received a live vaccine within 30 days before joining the study.
  • Be determined by the study leader to be unsuitable for participation.

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