GCC19CART for Patients With Metastatic Colorectal Cancer
Trial Parameters
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 refractory metastatic colorectal cancer.
Eligibility Criteria
Inclusion Criteria: * 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 Tu