GCC19CART treatment for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety and effectiveness of GCC19CART, a chimeric antigen receptor therapy, in adults with relapsed or refractory metastatic colorectal cancer. Participants must have a confirmed diagnosis of metastatic colorectal cancer and show positivity for guanylate cyclase (GCC) in their tumor tissue. The study aims to assess the pharmacokinetics and pharmacodynamics of the treatment, along with its clinical activity and tolerability. Eligible patients will have previously undergone standard chemotherapy regimens without surgical options for cure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults \> 18 years old
* Clinical and histopathological diagnosis of relapsed or refractory metastatic colorectal cancer
* Eastern Cooperative Oncology Group performance status of 0 or 1
* 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 lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 standard

Exclusion Criteria:

* Participants with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive tract, urinary bladder, or blood vessel) with LYL273 therapy
* Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT)
* History of or active viral infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement in the 2-year period leading up to the study enrollment
* No active infectious diseases or comorbid conditions that would interfere with safety or data quality
* Pregnant or breast-feeding women

Other protocol defined Inclusion/Exclusion criteria may apply

Where it's running

• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• University of California San Francisco Medical Center
  San Francisco, California, United States Recruiting
• University of Colorado Hospital - Anschutz Cancer Pavilion
  Aurora, Colorado, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• SCRI Oncology Partners and Tristar Centennial Hospital
  Nashville, Tennessee, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.