GCC19CART treatment for metastatic colorectal cancer
A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
PHASE1 · Lyell Immunopharma, Inc. · NCT05319314
This study is testing a new treatment called GCC19CART for adults with advanced colorectal cancer that hasn't responded to other therapies to see if it can help them.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lyell Immunopharma, Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Duarte, California and 3 other locations) |
| Trial ID | NCT05319314 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with metastatic colorectal cancer that is GCC positive and has not responded to standard therapies.
Not a fit: Patients with curable surgical options or those who have not received prior chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment alternatives.
How similar studies have performed: Other studies using CAR therapies for various cancers have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Duarte, California and 3 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, relapsed metastatic colorectal cancer, refractory metastatic colorectal cancer, chimeric antigen receptors, colorectal cancer