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

ClinicalTrials.gov ID

NCT05568680

Lead Sponsor

Verismo TherapeuticsINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

42Estimated

Last Update Posted

Jun 24, 2026Actual

Start Date

Mar 30, 2023Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

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

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.

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.

• Ovarian Cancer
• Cholangiocarcinoma Recurrent
• Mesothelioma, Malignant

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Verismo TherapeuticsINDUSTRY

ZZhang11@mdanderson.org832-729-0975

• Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110 in Cancer Studies

  NCT06377202

  WithdrawnObservationalUpdated Nov 7, 2024
• An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.

  NCT07420010

  Not yet recruitingInterventionalEarly Phase 1Updated Feb 19, 2026
• Autologous Redirected RNA Meso-CIR T Cells

  NCT01355965

  CompletedInterventionalPhase 1Updated Sep 19, 2017
• SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors

  NCT06562647

  RecruitingInterventionalNot ApplicableUpdated Feb 13, 2026
• Anti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors

  NCT02930993

  Unknown statusInterventionalPhase 1Updated Oct 12, 2016
• Anti-mesothelin CAR-T Cells With Advanced Refractory Solid Tumors

  NCT04981691

  Unknown statusInterventionalPhase 1Updated Sep 17, 2021