Trial Title:
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
NCT ID:
NCT05568680
Condition:
Ovarian Cancer
Cholangiocarcinoma Recurrent
Mesothelioma, Malignant
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cholangiocarcinoma
Mesothelioma
Mesothelioma, Malignant
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Description:
Autologous T cells Transduced with Mesothelin KIR-CAR
Arm group label:
SynKIR-110
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nurse Navigation
Phone:
913-945-7552
Email:
CTNurseNav@kumc.edu
Contact backup:
Last name:
Raed Al-Rajabi, MD
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea Standish
Phone:
215-662-2419
Email:
andrea.standish@pennmedicine.upenn.edu
Contact backup:
Last name:
Janos Tanyi, MD, PhD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachelle David, BSN,RN
Phone:
281-684-5271
Email:
rsdavid@mdanderson.org
Contact backup:
Last name:
Mehmet Altan, MD
Facility:
Name:
University of Wisconsin Carbone Cancer Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Connect
Phone:
800-622-8922
Email:
earlyphase@cancer.wisc.edu
Contact backup:
Last name:
Zhubin Gahvari, MD
Start date:
March 30, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Verismo Therapeutics
Agency class:
Industry
Source:
Verismo Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05568680
