SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
NCT ID: NCT05568680
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2023-03-30
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SynKIR-110
Single dose gravity drip IV administration
SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T cells Transduced with Mesothelin KIR-CAR
Interventions
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SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T cells Transduced with Mesothelin KIR-CAR
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Verismo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Johnson, PhD
Role: STUDY_DIRECTOR
Verismo Therapeutics
Locations
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University of Kansas Cancer Center
Westwood, Kansas, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STAR-101
Identifier Type: -
Identifier Source: org_study_id
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