RECRUITINGPhase 1INTERVENTIONAL
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
A Phase 1 Study of SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, or Mesothelioma
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 weakened immune system or have recognized weakened immune system disease
- Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
- Active autoimmune conditions (where your immune system attacks your own body)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
* 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
Treatments Being Tested
BIOLOGICAL
SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T cells Transduced with Mesothelin KIR-CAR
Locations (4)
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States