What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, diarrhea, fatigue, and neuropathy. Targeted therapies, which focus on specific molecules involved in cancer growth, may lead to skin problems, hypertension, and gastrointestinal issues. Immunotherapy, including CAR-T cell therapy like GCC19CART, can cause cytokine release syndrome (CRS), which leads to fever, fatigue, and low blood pressure, as well as neurotoxicity, which can result in confusion, seizures, and headaches. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapy, targeted therapy, and immunotherapy. Notably, treatments such as pembrolizumab and nivolumab, which are immune checkpoint inhibitors, have been approved for colorectal cancer with specific genetic markers like microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). While CAR-T cell therapies like GCC19CART are still under investigation for colorectal cancer, they represent a promising area of research. Currently, there are no FDA-approved CAR-T cell therapies specifically for colorectal cancer.

What other types of research exist?

Promising novel alternatives to GCC19CART for colorectal cancer patients include: 1) Pembrolizumab (an anti-PD-1 therapy) for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, 2) Nivolumab plus Ipilimumab (combination immunotherapy) for MSI-H/dMMR tumors, 3) Trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate) for HER2-positive tumors, and 4) Regorafenib (a multi-kinase inhibitor) for refractory metastatic colorectal cancer. These therapies have shown efficacy in clinical trials and are considered promising for 2024.

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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

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called GCC19CART for patients with colorectal cancer that has returned or not responded to other treatments. The treatment uses specially modified immune cells to target and kill cancer cells.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is in a place where treatment could harm an organ.

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I do not have a fever or an active infection needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer (CRC) include chemotherapy, targeted therapies, and emerging immunotherapies like CAR-T cell therapy. Chemotherapy, such as FOLFOX (oxaliplatin, leucovorin, and fluorouracil), works by damaging the DNA of cancer cells, preventing their replication. Targeted therapies, like cetuximab, inhibit specific molecules involved in cancer cell growth, such as the epidermal growth factor receptor (EGFR). CAR-T cell therapy, including GCC19CART, involves modifying a patient's T cells to target and destroy cancer cells expressing specific antigens like guanylyl cyclase C (GCC). This personalized approach can enhance the immune system's ability to fight cancer, offering hope for more effective and durable responses in CRC patients. Understanding these mechanisms helps patients and doctors choose the most appropriate and potentially effective treatment options.

Anthocyanins in Colorectal Cancer Prevention. A Systematic Review of the Literature in Search of Molecular Oncotargets.