Treatment for advanced cancers expressing mesothelin
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
Run by Verismo Therapeutics · NCT05568680 · Data updated 2026-11-12
This study is testing a new treatment called SynKIR-110 to see if it is safe and works for people with advanced cancers that have a specific protein called mesothelin, like ovarian cancer and mesothelioma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Verismo Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Tampa, Florida and 4 other locations) |
| Status | Recruiting |
| Started | March 30, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT05568680 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with pathologically confirmed recurrent advanced ovarian cancer, cholangiocarcinoma, or mesothelioma after at least one prior systemic therapy.
✕Probably not a fit
Patients with active invasive cancers other than the specified types or those with a history of T or B cell malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial evaluates the safety and feasibility of a single intravenous dose of SynKIR-110 in patients with advanced mesothelin-expressing tumors, including ovarian cancer, cholangiocarcinoma, and mesothelioma. The study involves a multicenter, open-label, dose-escalation design, where up to 42 subjects will receive treatment and be monitored for safety and potential activity. Participants will undergo a screening period, followed by a treatment phase with lymphodepleting chemotherapy and the investigational product, and will be followed for 12 months or until disease progression.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that currently have limited treatment options.
How similar studies have gone: While this approach is novel, similar studies targeting mesothelin-expressing tumors have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States Recruiting -
University of Kansas Cancer Center
Westwood, Kansas, United States Active not recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating a new CAR T-cell therapy for solid tumors expressing MSLN
This study is testing a new CAR T-cell therapy to see if it can safely treat adults with solid tumors like colorectal and lung cancer that express a specific protein.
-
Analyzing solid tumors for HLA loss and collecting T cells for CAR T-cell therapy
This study is testing how often solid tumors lose a key protein that helps the immune system recognize them, while also collecting T cells from patients with high-risk cancers to prepare for future CAR T-cell therapy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
CR-002 study in adults with advanced solid tumors
This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors
-
VT-101 in Advanced Ovarian Cancer: early safety study in adults
This early-phase trial tests VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer to see if it is safe, how the body handles it, and whether there are any initial signs of activity.
-
Methylation markers in self-samples to help detect gynecological cancers
This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.