Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05319314

GCC19CART for Patients With Metastatic Colorectal Cancer

Led by Lyell Immunopharma, Inc. · Updated on 2026-02-27

30

Participants Needed

4

Research Sites

513 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

GCC19CART for Patients With Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults > 18 years old
  • Clinical and histopathological diagnosis of metastatic colorectal cancer
  • Guanylate Cyclase (GCC) positive disease confirmed by immunohistochemistry of tumor tissue
  • Limited liver disease with fewer than 7 lesions and largest lesion less than 3 cm
  • No surgical options with curative intent
  • Prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in advanced/metastatic setting
  • Received anti-vascular endothelial growth factor (anti-VEGF) therapy if not contraindicated
  • For RAS wild-type patients, received anti-epidermal growth factor receptor (anti-EGFR) therapy per guidelines
  • Treatment discontinued due to disease progression or intolerance
  • At least one extracranial measurable target lesion per RECIST 1.1 criteria
Not Eligible

You will not qualify if you...

  • Tumor lesions located where GCC19CART therapy may cause organ or structure perforation
  • Active infectious diseases or comorbid conditions interfering with safety or data quality
  • Active infection requiring systemic therapy or fever over 38.1°C within 7 days prior to enrollment
  • Unexplained fever over 38.1°C within 7 days prior to enrollment
  • Pregnant or breastfeeding women
  • Other protocol-defined inclusion/exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

2

University of California San Francisco Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

3

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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GCC19CART for Patients With Metastatic Colorectal Cancer | DecenTrialz