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

V

Verismo Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Cholangiocarcinoma Recurrent
Mesothelioma, Malignant
Ovarian Cancer

Treatments

Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT05568680
STAR-101

Details and patient eligibility

About

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.

Full description

This is a Phase 1, FIH, multicenter, open-label, dose-escalation pilot study of a single IV gravity drip infusion of SynKIR-110 in subjects with advanced, mesothelin-expressing tumors (ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or mesothelioma). Up to 42 subjects will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Informed consent will be obtained from subjects prior to participation in this study.

The study includes an initial tumor biomarker screening, followed by an enrollment screening period (which includes pre-leukapheresis safety/eligibility and leukapheresis visits), treatment period (administration of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of investigational product), and a 12-month follow-up period or until disease progression. Subjects will be followed for 12 months or until disease progression, at which point they will be invited to participate in a long-term safety follow-up study.

Up to 6 cohorts of 3 to 6 subjects per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Doses will be escalated following a standard 3 + 3 design until either an MTD or MFD is reached. An additional 6 to 9 subjects will be enrolled at the MTD/MFD to further assess safety and potential activity of SynKIR-110.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
  • For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10% of cells at any staining intensity (≥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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

SynKIR-110
Experimental group
Description:
Single dose gravity drip IV administration
Treatment:
Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

Trial contacts and locations

3

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Central trial contact

Emily Winters, MS; Andrea Campanile, MS

Data sourced from clinicaltrials.gov

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