GCC19CART for Patients With Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovative Cellular Therapeutics Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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