Study on Immunotherapy Treatment for Ovarian Cancer and Other Advanced Cancers

Sponsor: University of Chicago

Sponsor score: 0

ClinicalTrials ID:NCT07389239

This clinical trial is exploring the safety and best dose of a new immunotherapy treatment using gene-modified T cells, with or without the drug decitabine, for patients with advanced cancers that express specific proteins called cancer-testis antigens.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment involving gene-modified T cells, which are a type of immune cell, to see if they can help treat advanced cancers that express certain proteins known as cancer-testis antigens. The study will also evaluate the safety and best dose of this treatment, with or without the addition of the drug decitabine.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with advanced solid tumors that cannot be removed by surgery.
  • Tumors must show a specific protein called NY-ESO-1.
  • Patients must have tried at least two standard treatments, such as chemotherapy or immunotherapy, and either not responded or been unable to continue them.
  • Specific criteria for different types of cancer, such as ovarian cancer, soft tissue sarcoma, and others, must be met.
  • Patients must have a life expectancy of more than 3 months.
  • Must have at least one measurable tumor.
  • Must be willing to provide a tumor sample for testing.
  • Must have a specific genetic marker called HLA-A*0201.
  • Must have normal organ and blood function based on specific tests.
  • Women of childbearing potential must agree to use effective birth control during the study and for 6 to 12 months after.
  • Must be able to understand and sign a consent form.
  • Must have a caregiver available and live within 45 minutes of the study site for a period after hospital discharge.

Exclusion Criteria

  • Currently receiving other experimental treatments.
  • History of severe allergic reactions to similar treatments.
  • Uncontrolled illnesses, such as heart failure or active infections.
  • Active autoimmune diseases requiring high doses of steroids.
  • History of certain bowel diseases or current colitis.
  • Need for systemic steroids or immunosuppressive drugs.
  • Active brain metastases unless previously treated and stable.
  • Dementia or mental conditions affecting consent or compliance.
  • Pregnant or breastfeeding women.
  • Lack of availability for follow-up assessments.
  • Abnormal lung function or low oxygen levels.
  • History of lung diseases like pneumonitis.
  • Fluid buildup in the body requiring frequent drainage.
  • Recent major surgery or live vaccines within 30 days before the study.

Locations

FACILITYZIPCITYSTATE
University of Chicago Medicine Comprehensive Cancer Center60637ChicagoIllinois

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