Status:
UNKNOWN
GCC19CART for Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Innovative Cellular Therapeutics Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refrac...
Eligibility Criteria
Inclusion
- Adults \> 18 years old
- Clinical and histopathological diagnosis of metastatic colorectal cancer
- Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC). Positivity on staining of archival tumor tissue is adequate.
- Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
- No surgical options with curative intent.
- Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy.
- Have at least one extracranial measurable target lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.
Exclusion
- Subjects with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive track, urinary bladder, or blood vessel) with GCC19CART therapy.
- No active infectious diseases or comorbid conditions that would interfere with safety or data quality.
- Subjects with active infection requiring systemic therapy or causing fever (temperature \> 38.1˚C) or subjects with unexplained fever (temperature \> 38.1˚C) within 7 days prior to enrollment (leukapheresis) and reconfirmed prior to the day of investigational product administration.
- Pregnant or breast-feeding women
- Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05319314
Start Date
August 1 2022
End Date
October 1 2024
Last Update
June 5 2023
Active Locations (6)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
3
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215-5418