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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Biological/VaccineAutologous T cells Transduced with Mesothelin KIR-CAR
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: SynKIR-110Experimental treatment 1 intervention
Trial outcomes
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
Time frame
Up to 12 monthsSecondary outcomes
1
Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 dose
Define the MTD or MFD of SynKIR-110
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov