Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05568680

Recruiting

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

Interventional

Phase 1

University of Pennsylvania

Sponsor: Verismo Therapeutics

Last Updated: February 10, 2026
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Cell Therapy

Required Mutations

Mesothelin

Trial Started

March 30, 2023

Last Updated by Sponsor

February 10, 2026

Estimated Completion

December 1, 2027

Contact Study

Name:Physician Connect

Email:physician.connect@verismotherapeutics.com

Phone:267-392-6847

Eligibility

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.

* 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

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll42

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Single dose gravity drip IV administration

Interventions:

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

Outcome Measures

Primary Outcome Measures

Safety and Feasibility of SynKIR-110Up to 12 months

* The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, Incidence of CRS and/or neurologic toxicity * Frequency of subjects who pass screening to enrollment but do not receive SynKIR-110

Secondary Outcome Measures

Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 doseUp to 12 months

Define the MTD or MFD of SynKIR-110

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Trial Sites

This study has 4 trial sites

University of Pennsylvania

Philadelphia, Pennsylvania, US

Name:Andrea Standish

Email:andrea.standish@pennmedicine.upenn.edu

Phone:215-662-2419

Recruiting

Philadelphia, Pennsylvania, 19104 US

University of Pennsylvania

Recruiting

Houston, Texas, 77030 US

MD Anderson Cancer Center

Recruiting

Westwood, Kansas, 66205 US

University of Kansas Cancer Center

Recruiting

Madison, Wisconsin, 53792 US

University of Wisconsin Carbone Cancer Center

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