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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568680
• Other study ID #: STAR-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 30, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: March 2024
• Source: Verismo Therapeutics
• Contact: Mala K Talekar, MBBS,DABP
• Phone: 267.331.3800
• Email: mala.talekar[@]verismotherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 30, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Cholangiocarcinoma
• Cholangiocarcinoma Recurrent
• Mesothelioma
• Mesothelioma, Malignant
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	MDAnderson	Houston	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Verismo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Date of enrollment through date of last patient visit, up to 36 months.
Secondary	Define the MTD or MFD of SynKIR-110	Define the MTD or MFD of SynKIR-110	Date of enrollment until the MTD is defined, up to 18 months