SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVerismo Therapeutics
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Treatment groups
42 Participants
are divided into 1 treatment groupLocations
5Moffitt Cancer Center33612, TampaFlorida, United States
University of Kansas Cancer Center66205, WestwoodKansas, United States
University of Pennsylvania19104, PhiladelphiaPennsylvania, United States
MD Anderson Cancer Center77030, HoustonTexas, United States
Sponsors and collaborators
Verismo Therapeutics
Lead sponsor
Source ClinicalTrials.gov