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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05568680
Recruitment Status : Recruiting
First Posted : October 6, 2022
Last Update Posted : May 16, 2024
Information provided by (Responsible Party):
Verismo Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Cholangiocarcinoma Recurrent Mesothelioma, Malignant Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2023
Estimated Primary Completion Date : March 15, 2026
Estimated Study Completion Date : March 30, 2026

Arm Intervention/treatment
Experimental: SynKIR-110
Single dose gravity drip IV administration
Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T cells Transduced with Mesothelin KIR-CAR

Primary Outcome Measures :
  1. Safety and feasibility of SynKIR-110 [ Time Frame: Date of enrollment through date of last patient visit, up to 36 months. ]
    • The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity

Secondary Outcome Measures :
  1. Define the MTD or MFD of SynKIR-110 [ Time Frame: Date of enrollment until the MTD is defined, up to 18 months ]
    Define the MTD or MFD of SynKIR-110

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05568680

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Contact: Mala K Talekar, MBBS,DABP 267.331.3800
Contact: Loretta Brozena, BSN, MBA 267.392.6838

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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie Elkins    215-615-6740   
Principal Investigator: Janos Tanyi, MD, PhD         
United States, Texas
MDAnderson Recruiting
Houston, Texas, United States, 77030
Contact: Rachelle David, BSN,RN    281-684-5271   
Principal Investigator: Mehmet Altan, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact    800-622-8922   
Sponsors and Collaborators
Verismo Therapeutics
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Study Director: Mala K Talekar, MBBS,DABP Verismo Therapeutics
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Responsible Party: Verismo Therapeutics Identifier: NCT05568680    
Other Study ID Numbers: STAR-101
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Mesothelioma, Malignant
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pleural Neoplasms
Lung Diseases