Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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 metastatic disease as determined by immunohistochemistry (IHC) from a new biopsy of a proposed target lesion.
  • Limited liver disease (less than 5 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 metastatic setting (or palliative therapy within 12 months of adjuvant therapy), an anti-vascular endothelial growth factor (anti-VEGF) biological therapy, 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 two extracranial measurable target lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.

You CAN'T join if...

  • Subjects with unresectable or metastatic microsatellite instability-high or mismatch repair deficient tumors.
  • 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 the day of investigational product administration.
  • Pregnant or breast-feeding women

Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • University of California San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • Dana-Farber Cancer Institute not yet accepting patients
    Boston Massachusetts 02215-5418 United States

Details

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