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
Verismo Therapeutics
Summary
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.
Description
This is a Phase 1, FIH, multicenter, open-label, dose-escalation pilot study of a single IV gravity drip infusion of SynKIR-110 in subjects with advanced, mesothelin-expressing tumors (ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or mesothelioma). Up to 42 subjects will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Informed consent will be obtained from subjects prior to participation in this study. The study includes an enrollment screening period (which includes pre-leukapheresis safety/eligibility and leukapheresi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalSynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T cells Transduced with Mesothelin KIR-CAR
Locations (4)
- University of Kansas Cancer CenterWestwood, Kansas
- University of PennsylvaniaPhiladelphia, Pennsylvania
- MD Anderson Cancer CenterHouston, Texas
- University of Wisconsin Carbone Cancer CenterMadison, Wisconsin