Study of SynKIR-110 Autologous T cells Transduced with Mesothelin KIR-CAR in Subjects with Mesothelin-Expressing Advanced Ovarian Cancer Cholangiocarcinoma or Mesothelioma (STAR)
Recruiting
18 years - 99 years
All
Phase
1
10 participants needed
5 Locations
Brief description of study
This study involves research of an investigational therapy called SynKIR-110. SynKIR-110 is CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient’s T cells (white blood cells that are a part of the immune system) are changed in a laboratory so they can attack cancer cells. The purpose of this research study is to identify a safe dose of SynKIR-110 in patients with advanced Ovarian cancer, Cholangiocarcinoma (bile duct cancer) or Mesothelioma (a tumor of the tissue that lines the lungs, stomach, heart, and other organs).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ovarian Cancer, Cholangiocarcinoma, Mesothelioma
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Age: 18 years - 99 years
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Gender: All
Inclusion 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
Exclusion Criteria:
- 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
Updated on
21 Dec 2024.
Study ID: 852470
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