GCC19CART for Patients With Metastatic Colorectal Cancer

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

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 Tumors (RECIST) 1.1 standard.

Exclusion Criteria:

* 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

Conditions2

Locations4 sites

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