RecruitingPhase 1NCT05568680

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

Sponsor

Verismo Therapeutics

Enrollment

42 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Mesothelioma, Malignant Cholangiocarcinoma Recurrent

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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