GCC19CART for Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

— CARAPIA-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319314
• Other study ID #: ICT-GCC19CART-US-001
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Innovative Cellular Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• GCC19CART
Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Colorado Hospital - Anschutz Cancer Pavilion	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	University of California San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Cellular Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study		Infusion (Day 0) up to Day 28
Primary	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
Primary	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	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
Secondary	Duration of Response (DOR)	The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).	Infusion (Day 0) up to approximately 12 months
Secondary	Progression Free Survival (PFS)	Progression free survival (PFS) time which is defined as time from date of leukapheresis until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first.	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.
Secondary	Overall Survival (OS)	Overall survival (OS) is defined as the time from the date of leukapheresis until death from any cause.	Day 30 (date of leukapheresis) up to approximately 13 months or until death from any cause
Secondary	Copy number of Guanylate Cyclase C (GCC) by Quantitative Polymerase Chain Reaction (qPCR)		Infusion, Inpatient Monitoring and Post Treatment Period (Up to 12 months)
Secondary	Copy number of each individual CD19 by Quantitative Polymerase Chain Reaction (qPCR)		Infusion, Inpatient Monitoring and Post Treatment Period (Up to 12 months)
Secondary	Cytokine level in serum		Infusion (Day 0) up to 12 months post treatment
Secondary	AUC0 - Tmax: The area under curve (AUC) from time zero to Tmax in peripheral blood (days x copies/µg)		Infusion (Day 0) up to 12 months post treatment
Secondary	AUCTmax - 28d and/or AUCTmax - 84d: The area under curve (AUC) from time Tmax to day 28 and/or AUCTmax - 84d or other disease assessment days, in peripheral blood (days x copies/µg)		Infusion (Day 0) up to 12 months post treatment
Secondary	AUC0 - 28d and/or AUC0 - 84d: The area under curve (AUC) from time zero to day 28 and/or day 84 in peripheral blood (days x copies/µg)		Infusion (Day 0) up to 12 months post treatment
Secondary	Cmax: The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (copies/µg)		Infusion (Day 0) up to 12 months post treatment
Secondary	Tmax: The time to reach maximum(peak) in peripheral blood or other body fluid drug concentration after single dose administration (days)		Infusion (Day 0) up to 12 months post treatment