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New treatment option for Ovarian Cancer
Official title SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
ClinicalTrials.gov ID: NCT05568680
What this study is testing
What is SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR?
SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or...
- 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
You likely can't join if
- Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent...
- 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
See the full 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Westwood, Kansas, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Westwood, Kansas, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.