This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05319314
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : June 5, 2023
Sponsor:
Information provided by (Responsible Party):
Innovative Cellular Therapeutics Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: GCC19CART Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: GCC19CART

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. 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 ]
  2. Duration of Response (DOR) [ Time Frame: Infusion (Day 0) up to approximately 12 months ]
    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).

  3. Progression Free Survival (PFS) [ 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. ]
    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.

  4. Overall Survival (OS) [ Time Frame: Day 30 (date of leukapheresis) up to approximately 13 months or until death from any cause ]
    Overall survival (OS) is defined as the time from the date of leukapheresis until death from any cause.

  5. 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) ]
  6. 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) ]
  7. Cytokine level in serum [ Time Frame: Infusion (Day 0) up to 12 months post treatment ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05319314


Locations
Layout table for location information
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Marwan Fakih    877-467-3411    mfakih@coh.org   
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Harika Gopi    415-818-4579    HDFCCC.CIP@ucsf.edu   
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Meredith Waring    720-848-9457    meredith.waring@cuanschutz.edu   
Contact: Nadine Salvador    720-848-5097    nadine.salvador@cuanschutz.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215-5418
Contact: Christopher Simmons    617-632-6218    Christopher_Simmons@dfci.harvard.edu   
United States, Michigan
University of Michigan Comprehensive Cancer Center Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Patricia Boykin       Patricia.Boykin@Labcorp.com   
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75204
Contact: CORC Solid Tumor    214-820-6168    corcsolidtumor@BSWHealth.org   
Contact: Tyler Clifford    214-820-6168    Tyler.clifford@bswhealth.org   
Sponsors and Collaborators
Innovative Cellular Therapeutics Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Innovative Cellular Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05319314    
Other Study ID Numbers: ICT-GCC19CART-US-001
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Innovative Cellular Therapeutics Inc.:
relapsed metastatic colorectal cancer
refractory metastatic colorectal cancer
chimeric antigen receptors (CAR)
colorectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases