NCT05568680

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 ovarian-cancer

Timeline
19mo left

Started Mar 2023

Typical duration for phase_1 ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Mar 2023Dec 2027

First Submitted

Initial submission to the registry

September 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 10, 2026

Status Verified

October 1, 2025

Enrollment Period

4.7 years

First QC Date

September 28, 2022

Last Update Submit

February 6, 2026

Conditions

Ovarian CancerCholangiocarcinoma RecurrentMesothelioma, Malignant

Outcome Measures

Primary Outcomes (1)

  • Safety and Feasibility of SynKIR-110

    * 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

    Up to 12 months

Secondary Outcomes (1)

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

    Up to 12 months

Study Arms (1)

SynKIR-110

EXPERIMENTAL

Single dose gravity drip IV administration

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

Interventions

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

Autologous T cells Transduced with Mesothelin KIR-CAR

SynKIR-110

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsMesothelioma, Malignant

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Laura Johnson, PhD

    Verismo Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Physician Connect

CONTACT

267-392-6847physician.connect@verismotherapeutics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 6, 2022

Study Start

March 30, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 10, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)