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CAR T-cell Therapy

GCC19CART for Colorectal Cancer (CARAPIA-1 Trial)

Phase 1
Recruiting
Research Sponsored by Innovative Cellular Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC). Positivity on staining of archival tumor tissue is adequate
Clinical and histopathological diagnosis of metastatic colorectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infusion, inpatient monitoring and post treatment period (up to 12 months)
Awards & highlights

CARAPIA-1 Trial Summary

This trial is testing a new drug for safety and effectiveness in people with a certain type of cancer that has returned or does not respond to treatment.

Who is the study for?
This trial is for adults over 18 with metastatic colorectal cancer that can't be surgically removed. They must have tried certain chemotherapies and, if applicable, targeted therapies according to guidelines. Their disease must show GCC positivity and they should have limited liver involvement with measurable tumors outside the brain.Check my eligibility
What is being tested?
The study tests a new therapy called GCC19CART in patients whose metastatic colorectal cancer has not responded to or cannot tolerate standard treatments. It's an early-phase trial focusing on how safe it is, how well tolerated it is, its effectiveness, and how the body processes it.See study design
What are the potential side effects?
While specific side effects of GCC19CART are not listed here, typical risks may include immune reactions, potential organ damage at tumor sites due to inflammation caused by therapy, general discomforts like fatigue or fever from treatment-related responses.

CARAPIA-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is GCC positive based on a special tissue test.
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My diagnosis is metastatic colorectal cancer.
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I am over 18 years old.
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I've had specific chemotherapy and targeted therapy for my advanced cancer, but it either stopped working or I couldn't tolerate it.
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I have been told surgery cannot cure my condition.
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I have at least one tumor outside the brain that can be measured.
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My liver has fewer than 7 spots, with the biggest one smaller than 3 cm.

CARAPIA-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infusion, inpatient monitoring and post treatment period (up to 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and infusion, inpatient monitoring and post treatment period (up to 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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)
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)
+9 more

CARAPIA-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: GCC19CARTExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Innovative Cellular Therapeutics Inc.Lead Sponsor

Media Library

GCC19CART (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05319314 — Phase 1
Colorectal Cancer Research Study Groups: GCC19CART
Colorectal Cancer Clinical Trial 2023: GCC19CART Highlights & Side Effects. Trial Name: NCT05319314 — Phase 1
GCC19CART (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05319314 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has GCC19CART received official authorization from the FDA?

"Our Power associates have deemed GCC19CART to possess a level of safety equivalent to 1 on the 3-point scale. This is because this Phase 1 trial has only limited information regarding its efficacy and security profile."

Answered by AI

How many healthcare facilities have implemented this research protocol?

"In total, there are 6 medical centres participating in this study. These include the University of Michigan Comprehensive Cancer Center (Ann Arbor), Baylor Scott & White Research Institute (Dallas) and University of Colorado Hospital - Anschutz Cancer Pavilion (Aurora). Additionally, 3 other clinical trial sites are involved."

Answered by AI

How many subjects have been enrolled in this investigation?

"This research requires 30 qualified patients to join. University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan and Baylor Scott & White Research Institute in Dallas, Texas are two possible sites for participants to consider."

Answered by AI

Is recruitment ongoing for this research endeavor?

"According to records on clinicaltrials.gov, the medical trial is still in its recruitment phase. It was initially posted online August 1st of 2022 and revised recently on September 19th of that same year."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
Dana-Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
~12 spots leftby Mar 2025