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

This study is testing a new treatment called SynKIR-110 for people with advanced ovarian cancer, cholangiocarcinoma (bile duct cancer), or mesothelioma that expresses mesothelin (a protein found on some cancer cells). SynKIR-110 uses your own immune cells, called T cells, which are specially modified in a lab to target these cancer cells. The main goal of this study is to see how safe SynKIR-110 is and if it's possible to give this treatment. Researchers will also look for early signs of whether the treatment is working. You might be able to join if you are 18 or older, have one of these cancers that has come back or spread after at least one other treatment, and have a good general health status (ECOG performance status of 0 to 1). This study plans to enroll up to 42 participants.

Study design
This is a Phase 1, first-in-human, multicenter, open-label, dose-escalation pilot study. Up to 42 participants will be treated in different groups to find the safest dose.
What's involved
You will go through a screening period, receive chemotherapy followed by a single infusion of SynKIR-110, and then have follow-up visits for 12 months or until your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months or until their disease progresses, whichever comes first. After this, they may be invited to a long-term safety follow-up study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05568680

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Verismo Therapeutics
~42 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Feasibility of SynKIR-110
Measured over Up to 12 months
Ovarian Cancer
Cholangiocarcinoma Recurrent
Mesothelioma, Malignant
5 sites across 5 states
Florida1
Kansas1
Pennsylvania1
Texas1
Wisconsin1

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Eligibility criteria

Inclusion

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

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
  • 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