What side effects are associated with this type of intervention?

Common treatments for stomach cancer, particularly immunotherapies and engineered T-cell therapies like KK-LC-1 TCR-T cells, often have side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Additionally, cytokine release syndrome (CRS) and neurotoxicity are notable side effects specific to T-cell therapies. These adverse events can vary in severity and necessitate vigilant monitoring and management.

What prior FDA approvals exist?

FDA-approved treatments for stomach cancer include various immunotherapies and targeted therapies. Notably, pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors approved for advanced gastric cancer. These drugs target the PD-1/PD-L1 pathway to enhance the immune system's ability to fight cancer. While specific FDA approvals for engineered T cells targeting KK-LC-1 antigen are not mentioned, the use of chimeric antigen receptor (CAR) T cell therapies, such as those targeting mesothelin (MSLN) and other antigens, represents a similar approach in immunotherapy for gastric adenocarcinoma.

What other types of research exist?

Promising novel alternatives to KK-LC-1 TCR-T cells for stomach cancer patients include: 1) LY6K-177 peptide vaccine therapy, which has shown immunogenicity in advanced esophageal cancer and is being extended to gastric cancer. 2) P-PSMA-101 CAR-T cells, which are being studied in metastatic castration-resistant prostate cancer but may have potential applications in other cancers. 3) Modified IL-2 agents like NKTR-214, designed to activate CD8+ and NK cells, which could enhance the immune response against tumors. These alternatives are in various stages of clinical trials and may offer new treatment options for stomach cancer patients.

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CAR T-cell Therapy

TCR-T Cell Therapy for Cancer

Q: What is the mechanism of action of this treatment?

Stomach cancer treatments often involve immunotherapy, which leverages the body's immune system to target and destroy cancer cells. One promising approach is TCR-T cell therapy, where T cells are engineered to recognize and attack cancer cells expressing specific antigens like KK-LC-1. This method enhances the immune system's ability to target cancer cells more precisely. Additionally, immune checkpoint inhibitors, such as those targeting PD-1/PD-L1 pathways, help to prevent cancer cells from evading immune detection. These treatments are significant for stomach cancer patients as they offer targeted, potentially more effective options with the possibility of fewer side effects compared to traditional therapies.

Phase 1

Recruiting

Led By Christian S Hinrichs, MD

Research Sponsored by Christian Hinrichs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with < 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment using modified immune cells to target specific cancers. It focuses on patients with certain metastatic cancers that produce an abnormal protein. The treatment aims to use the body's own enhanced immune system to fight cancer.

Who is the study for?

This trial is for adults over 18 with metastatic gastric, breast, cervical, or lung cancer that tests positive for KK-LC-1. They must have tried standard treatments without success and be in good physical condition (ECOG 0 or 1). Participants need functioning organs/marrow and no active infections like HIV or hepatitis. Pregnant women can't join, and those who can bear children must use contraception.

What is being tested?

The trial is testing the safety and maximum dose of KK-LC-1 TCR-T cells combined with aldesleukin in treating certain cancers. It's a phase I study to see how patients tolerate this treatment and what their clinical response will be after receiving a conditioning regimen followed by the therapy.

What are the potential side effects?

Possible side effects may include reactions related to immune cell infusion such as fever, fatigue, chills; organ inflammation due to immune response; issues from high-dose aldesleukin including low blood pressure, fluid buildup; plus general risks associated with cancer immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have up to 3 brain metastases treated with surgery or radiosurgery and stable for 1 month.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My organ and bone marrow functions are within normal ranges.

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It's been over 4 weeks since my last cancer treatment and any side effects are mild or stable.

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I am older than 18 years.

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My cancer is advanced and tests positive for KK-LC-1 in at least 25% of cells.

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My genetic test shows I have the HLA-A*01:01 allele.

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My heart pumps well, confirmed by a heart scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

T-Cell Receptor

Secondary study objectives

Adverse events of KK-LC-1 TCR T cells

Tumor response duration

Tumor response rate

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: KK-LC-1 TCR-T cellsExperimental Treatment2 Interventions

Subjects will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

2012

Completed Phase 4

~1610

0 / 8Eligibility 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

Stomach cancer treatments often involve immunotherapy, which leverages the body's immune system to target and destroy cancer cells. One promising approach is TCR-T cell therapy, where T cells are engineered to recognize and attack cancer cells expressing specific antigens like KK-LC-1. This method enhances the immune system's ability to target cancer cells more precisely. Additionally, immune checkpoint inhibitors, such as those targeting PD-1/PD-L1 pathways, help to prevent cancer cells from evading immune detection. These treatments are significant for stomach cancer patients as they offer targeted, potentially more effective options with the possibility of fewer side effects compared to traditional therapies.

Pathogenesis and treatment of gastric carcinoma: "an up-date with brief review".