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GCC19CART for Patients With Metastatic Colorectal Cancer (CARAPIA-1)

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GCC19CART

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring relapsed metastatic colorectal cancer, refractory metastatic colorectal cancer, chimeric antigen receptors (CAR), colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Comprehensive Cancer CenterRecruiting
University of California San Francisco Medical CenterRecruiting
University of Colorado Hospital - Anschutz Cancer PavilionRecruiting
Dana-Farber Cancer InstituteRecruiting
University of Michigan Comprehensive Cancer Center
Baylor Scott & White Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GCC19CART

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

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).

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.

Overall Survival (OS)

Overall survival (OS) is defined as the time from the date of leukapheresis until death from any cause.

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

Copy number of each individual CD19 by Quantitative Polymerase Chain Reaction (qPCR)

Cytokine level in serum

AUC0 - Tmax: The area under curve (AUC) from time zero to Tmax in peripheral blood (days x copies/μg)

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)

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)

Cmax: The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (copies/μg)

Tmax: The time to reach maximum(peak) in peripheral blood or other body fluid drug concentration after single dose administration (days)

Full Information

NCT ID

NCT05319314

First Posted

March 23, 2022

Last Updated

June 2, 2023

Sponsor

Innovative Cellular Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05319314

Brief Title

GCC19CART for Patients With Metastatic Colorectal Cancer

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovative Cellular Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GCC19CART

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

GCC19CART

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Infusion (Day 0) up to Day 28

Title

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

Time Frame

Infusion (Day 0) up to Day 28

Title

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

Time Frame

Infusion (Day 0) up to Day 28

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

Duration of Response (DOR)

Description

Time Frame

Infusion (Day 0) up to approximately 12 months

Title

Progression Free Survival (PFS)

Description

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.

Time Frame

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.

Title

Overall Survival (OS)

Description

Overall survival (OS) is defined as the time from the date of leukapheresis until death from any cause.

Time Frame

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

Title

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

Time Frame

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

Title

Copy number of each individual CD19 by Quantitative Polymerase Chain Reaction (qPCR)

Time Frame

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

Title

Cytokine level in serum

Time Frame

Infusion (Day 0) up to 12 months post treatment

Title

AUC0 - Tmax: The area under curve (AUC) from time zero to Tmax in peripheral blood (days x copies/μg)

Time Frame

Infusion (Day 0) up to 12 months post treatment

Title

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)

Time Frame

Infusion (Day 0) up to 12 months post treatment

Title

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)

Time Frame

Infusion (Day 0) up to 12 months post treatment

Title

Cmax: The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (copies/μg)

Time Frame

Infusion (Day 0) up to 12 months post treatment

Title

Tmax: The time to reach maximum(peak) in peripheral blood or other body fluid drug concentration after single dose administration (days)

Time Frame

Infusion (Day 0) up to 12 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marwan Fakih

Phone

877-467-3411

mfakih@coh.org

Facility Name

University of California San Francisco Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harika Gopi

Phone

415-818-4579

HDFCCC.CIP@ucsf.edu

Facility Name

University of Colorado Hospital - Anschutz Cancer Pavilion

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meredith Waring

Phone

720-848-9457

meredith.waring@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Nadine Salvador

Phone

720-848-5097

nadine.salvador@cuanschutz.edu

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215-5418

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Simmons

Phone

617-632-6218

Christopher_Simmons@dfci.harvard.edu

Facility Name

University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patricia Boykin

Patricia.Boykin@Labcorp.com

Facility Name

Baylor Scott & White Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

CORC Solid Tumor

Phone

214-820-6168

corcsolidtumor@BSWHealth.org

First Name & Middle Initial & Last Name & Degree

Tyler Clifford

Phone

214-820-6168

Tyler.clifford@bswhealth.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

GCC19CART for Patients With Metastatic Colorectal Cancer

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