GCC19CART for Patients With Metastatic Colorectal Cancer

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.

Conditions

Colorectal Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

GCC19CART for Patients With Metastatic Colorectal Cancer

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

San Francisco

University of California San Francisco Medical Center, San Francisco, California, United States, 94143

Aurora

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States, 80045

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215-5418

Ann Arbor

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States, 48109

Dallas

Baylor Scott & White Research Institute, Dallas, Texas, United States, 75204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innovative Cellular Therapeutics Inc.,

Study Record Dates

2024-10