SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
About this study
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.
- Condition
- Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant
- Tested
- SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
- Sponsor
- Verismo Therapeutics
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant
- 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.
- 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 7
- 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
Where
5 sites, 4 recruiting
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Potential match only. Final eligibility is determined by the study team.