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Clinical Trials in the USA / NCT05568680
Recruiting Phase 1

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

NCT05568680 · tracked via the Priya Life Science USA tracker
Sponsor
Verismo Therapeutics
Phase
Phase 1
Started
2023-03-30
Last updated
2026-06-24

Condition(s) studied

Ovarian CancerCholangiocarcinoma RecurrentMesothelioma, Malignant

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Safety and Feasibility of SynKIR-110 — Up 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

Trial sites (5)

FacilityCityRegionStatus
Moffitt Cancer Center Tampa Florida Recruiting
University of Kansas Cancer Center Westwood Kansas Active Not Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
University of Wisconsin Carbone Cancer Center Madison Wisconsin Recruiting

More Verismo Therapeutics trials in the USA

A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product Enrolling by invitation
SynKIR-310 for Relapsed/Refractory B-NHL Recruiting

Other trials for the same condition

Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors Active, not recruiting
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors Active, not recruiting
A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors Recruiting
Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer Recruiting
Safety in Ovarian Cancer for Average-Risk Women - Analysis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05568680 on ClinicalTrials.gov ↗ ← All trials in the USA