Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Bridget Keenan
Headshot of Bridget Keenan
Bridget Keenan

Description

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.

Official Title

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

Keywords

Colorectal Cancer, relapsed metastatic colorectal cancer, refractory metastatic colorectal cancer, chimeric antigen receptors (CAR), Colorectal Neoplasms, GCC19CART

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCSF

  • Bridget Keenan
    I am a physician scientist who works in translational cancer research and medical oncology. My clinical practice is in the Cancer Immunotherapy Clinic, where I work with patients with solid organ cancers who are being treated on early phase immunotherapy trials. I also attend on the Oncology Consult inpatient service.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Innovative Cellular Therapeutics Inc.
ID
NCT05319314
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated