STAR-101 Eligibility Criteria
- Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease
- Adult 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10% of cells at any staining intensity (≥1+).
- Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.
- Satisfactory Blood coagulation parameters:
- Satisfactory organ and bone marrow function
- Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.
- History of T or B cell malignancies or previous gene-engineered T cell therapies.
- Sarcomatoid/biphasic mesothelioma.
- Pulmonary exclusions:
- Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease
- Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
- Active autoimmune disease