A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
Lyell Immunopharma, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 the…
Interventions
- DrugGCC19CART
Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)
Locations (4)
- City of Hope Comprehensive Cancer CenterDuarte, California
- University of California San Francisco Medical CenterSan Francisco, California
- University of Colorado Hospital - Anschutz Cancer PavilionAurora, Colorado
- Dana-Farber Cancer InstituteBoston, Massachusetts