RECRUITING

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

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Conditions

Ovarian CancerCholangiocarcinoma RecurrentMesothelioma, Malignant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-30
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05568680

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Adult 18 years of age or older.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  4. * Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.
  5. * Satisfactory Blood coagulation parameters
  6. * Satisfactory organ and bone marrow function
  1. * Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.
  2. * History of T or B cell malignancies or previous gene-engineered T cell therapies.
  3. * Sarcomatoid/biphasic mesothelioma.
  4. * Pulmonary exclusions
  5. * Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease
  6. * Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
  7. * Active autoimmune disease

Contacts and Locations

Study Contact

Emily Winters, MS
CONTACT
267-392-6848
emily.winters@verismotherapeutics.com
Andrea Campanile, MS
CONTACT
andrea.campanile@verismotherapeutics.com

Principal Investigator

Laura Johnson, PhD
STUDY_DIRECTOR
Verismo Therapeutics

Study Locations (Sites)

University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Verismo Therapeutics

  • Laura Johnson, PhD, STUDY_DIRECTOR, Verismo Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-30
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-03-30
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Cholangiocarcinoma Recurrent
  • Mesothelioma, Malignant