Study on Immunotherapy Treatment for Ovarian Cancer and Other Advanced Cancers
Sponsor: University of Chicago
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | 60637 | Chicago | Illinois |
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