Study on the Safety and Effectiveness of Donor HPV-specific T Cells in Adults with Recurrent or Metastatic HPV16+ Cancers

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04713046

Provider View

This clinical trial is testing a new treatment using donor T cells that target HPV16+ cancers in adults whose cancer has returned or spread. The study aims to determine if this approach is safe and effective in managing the disease.

Patient Parameters

Program Overview

In this study, relatives of patients with recurrent or metastatic HPV16+ cancer will receive a vaccine to produce special immune cells that target HPV. The cancer patients will then be randomly assigned to one of two treatment groups: one group will receive a type of bone marrow transplant, and the other will receive a specific type of immune cell infusion.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of incurable, locally recurrent, or metastatic HPV16+ head and neck cancer.
  • Be 18 years or older.
  • Have a partially matched related donor, such as a parent, child, half-sibling, or other close relative.
  • Have previously received a platinum-based chemotherapy treatment.
  • If eligible for anti-PD-1 or anti-PD-L1 therapy, must have received at least one cycle before joining this trial.
  • Have a life expectancy of at least 4 months.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with a performance status score of less than 2.
  • Have adequate heart, liver, and kidney function based on specific medical tests.
  • Be willing and able to provide written consent to participate in the study.

Exclusion Criteria

  • Have cancer that can be treated with local therapy aimed at curing it.
  • Require support from a ventilator or medications to maintain blood pressure.
  • Have received certain immune-suppressing treatments within 4 weeks before starting the study.
  • Have an immune deficiency or are taking high doses of steroids or other immune-suppressing drugs.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have an active infection requiring treatment.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have received a live vaccine within 30 days before joining the study.
  • Have another progressing cancer needing treatment, except for certain skin cancers or non-HPV16 cervical cancer.
  • Be pregnant or breastfeeding.
  • Be unwilling to use effective birth control during the study and for 120 days after the last treatment.
  • Be unable to follow study procedures.
  • Have received chemotherapy or targeted therapy within 2 weeks before starting the study.
  • Have received radiation therapy within 2 weeks before starting the study.
  • Have cancer spread to the brain or spinal cord unless treated and stable.
  • Have a history of HIV, active hepatitis B, or hepatitis C.
  • Have previously received HPV T cell treatment.

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