GCC19CART for Patients With Metastatic Colorectal Cancer

NCT05319314 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ICT-GCC19CART-US-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Colorectal Cancer

Keywords

relapsed metastatic colorectal cancer; refractory metastatic colorectal cancer; chimeric antigen receptors (CAR); colorectal cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study

  Infusion (Day 0) up to Day 28

• Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study

  Infusion (Day 0) up to Day 28

• Recommended Phase 2 dose (RP2D) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study

  Infusion (Day 0) up to Day 28

Secondary Outcomes (12)

• Best overall response as measured by overall response rate based on the tumor size per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

  Infusion (Day 0) up to approximately 12 months or until disease progression/recurrence

• Duration of Response (DOR)

  Infusion (Day 0) up to approximately 12 months

• Progression Free Survival (PFS)

  Day 30 (date of leukapheresis) up to approximately 13 months or until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first.

• Overall Survival (OS)

  Day 30 (date of leukapheresis) up to approximately 13 months or until death from any cause

• Copy number of Guanylate Cyclase C (GCC) by Quantitative Polymerase Chain Reaction (qPCR)

  Infusion, Inpatient Monitoring and Post Treatment Period (Up to 12 months)

Study Arms (1)

GCC19CART

EXPERIMENTAL

Single infusion of GCC19CART at the dose assigned to an individual subject. All subjects will receive the same investigational therapy with the dose administered dependent upon the dose level they are assigned to in a sequential manner. Two dose level escalations are planned with one dose de-escalation listed if needed.

Drug: GCC19CART

Interventions

GCC19CART DRUG

Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)

GCC19CART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Lyell Immunopharma, Inc.: lead

Study Sites (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215-5418, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2032
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)