A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART in Subjects with Relapsed or Refractory Metastatic Colorectal Cancer (CARAPIA-1)

Protocol # :
Colorectal Cancer
Disease Sites
Principal Investigator
Schlechter, Benjamin

Trial Description

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 Requirements

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