Clinical Trial 24081

• Overview

  Study 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

  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.

  Objective:

  Primary: To evaluate the safety and feasibility of a single IV infusion of SynKIR-110 in subjects with advanced mesothelin-expressing solid tumors (ovarian cancer, cholangiocarcinoma, or mesothelioma)

• Treatments

  Therapies:

  An autologous anti-mesothelin (KIR-CAR) T cell therapy; Cell Therapy

  Medications:

  SynKIR-110 ()

• Inclusion 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

  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.

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