SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

Description

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.

Conditions

Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant

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Study Overview

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Study Details

Study overview

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.

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

SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Westwood

University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Madison

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Verismo Therapeutics,

Laura Johnson, PhD, STUDY_DIRECTOR, Verismo Therapeutics

Study Record Dates

2027-12