Recruiting
Phase 1

SynKIR-110

Sponsor:

Verismo Therapeutics

Code:

NCT05568680

Conditions

Ovarian Cancer

Cholangiocarcinoma Recurrent

Mesothelioma, Malignant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

Study Details

Brief 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.

Conditions

Ovarian Cancer

Cholangiocarcinoma Recurrent

Mesothelioma, Malignant

Study ID

NCT05568680

Start date

Mar 30, 2023

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 bone marrow function

Exclusion Criteria:

  • 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

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SynKIR-110

Single dose gravity drip IV administration

Interventions

SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

Autologous T cells Transduced with Mesothelin KIR-CAR

Primary outcome measure

  • Safety and Feasibility of SynKIR-110 [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Ashley O'Neil, MPH, LSSWB, CCRC

813-745-5240Ashley.ONeil@moffitt.org

Principal Investigator:

Ben Creelan, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Andrea Standish

215-662-2419andrea.standish@pennmedicine.upenn.edu

Principal Investigator:

Janos Tanyi, MD, PhD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Zheng Zhang

832-729-0975ZZhang11@mdanderson.org

Principal Investigator:

Mehmet Altan, MD

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Cancer Connect

800-622-8922CancerConnect@uwhealth.org

Principal Investigator:

Zhubin Gahvari, MD

More Information

Sponsor

Verismo Therapeutics

Last update posted

Jun 24, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Verismo Therapeutics on 2026-06-24.