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Recruiting NCT05568680

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

Phase I Interventional Ovarian Cancer Cholangiocarcinoma Recurrent Mesothelioma, Malignant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed 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 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 confirmed disease progression, whichever occurs first, 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 treated 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 treated at the MTD/MFD to further assess safety and potential activity of SynKIR-110.

Interventions

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

Primary outcome measures

  • Safety and Feasibility of SynKIR-110 [Time frame: Up to 12 months]
Secondary outcome measures (1)
  • Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 dose [Time frame: Up to 12 months]

Eligibility 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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Moffitt Cancer Center — Tampa
  • University of Kansas Cancer Center — Westwood
  • University of Pennsylvania — Philadelphia
  • MD Anderson Cancer Center — Houston
  • University of Wisconsin Carbone Cancer Center — Madison

Identifiers

NCT: NCT05568680 · STAR-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗