What side effects are associated with this type of intervention?

Common treatments for stomach cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, fatigue, and hair loss. Targeted therapies, like those inhibiting VEGFR or EGFR, may lead to hypertension, hand-foot syndrome, and proteinuria. Immunotherapy, including immune checkpoint inhibitors, can result in fatigue, skin rashes, and immune-related adverse events like colitis or pneumonitis. Specifically, CAR-T cell therapies, such as those targeting Claudin 18.2, can cause cytokine release syndrome (CRS), neurotoxicity, and cytopenias. These side effects vary in severity and require careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for stomach cancer, including immunotherapies and targeted therapies. Pembrolizumab, an anti-PD-1 antibody, has been approved for PD-L1-positive advanced gastric or gastroesophageal junction adenocarcinoma. Additionally, trastuzumab, a monoclonal antibody targeting HER2, is approved for HER2-positive gastric cancer. While specific FDA approvals for Claudin 18.2-targeted CAR T-cell therapies are not mentioned, these approvals reflect the broader trend of using targeted and immune-based therapies in stomach cancer treatment.

What other types of research exist?

Promising novel alternatives to Claudin 18.2-Targeted CAR T-cells for stomach cancer patients include: 1) Pembrolizumab, an anti-PD-1 antibody, which has shown efficacy in various cancers including gastric cancer. 2) Atezolizumab, an anti-PD-L1 antibody, which has demonstrated improved survival outcomes in combination with chemotherapy in other cancers. 3) Durvalumab, another anti-PD-L1 antibody, which has shown improved survival outcomes in combination with platinum-etoposide in small cell lung cancer and may have potential in gastric cancer. These immunotherapies represent advanced treatment options that could be considered in 2024.

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CAR T-cell Therapy

CAR T-cell Therapy for Stomach & Pancreatic Cancer

Phase 1

Recruiting

Research Sponsored by Legend Biotech USA Inc

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, a minimum of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment using modified immune cells to target and kill cancer cells in patients with advanced stomach, esophagus, or pancreatic cancer. The treatment focuses on cancers that have a specific protein. The treatment targets a specific protein found on certain cancer cells and has shown promise in previous studies for treating advanced stomach and esophagus cancers. The study aims to find the best dose for future use.

Who is the study for?

Adults aged 18-75 with advanced stomach, GEJ, esophageal, or pancreatic cancer that's not operable and hasn't responded to standard treatments can join. They must have tried certain chemotherapies before and have CLDN18.2 positive tumors. Good organ function is required, they should be in decent physical shape (ECOG 0 or 1), expect to live at least four more months, and agree to use effective birth control for a year after treatment.

What is being tested?

The trial tests LB1908 cells designed to target Claudin 18.2 on cancer cells in patients with specific types of advanced gastrointestinal cancers. It's an early-phase study where researchers will try different doses to see what’s safe and might work.

What are the potential side effects?

Potential side effects aren't detailed here but may include typical reactions from cellular therapies like immune system overactivity causing inflammation in various organs (cytokine release syndrome), infusion-related reactions, fatigue, digestive issues, blood disorders, increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, a minimum of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, a minimum of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a minimum of 2 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

To characterize the safety and tolerability of LB1908 and determine the optimal dose or recommended dose for expansion (RDE)

To further characterize the safety and tolerability of LB1908 with the RDE identified in the dose-escalation and determine the recommended Phase 2 dose (RP2D)

Secondary study objectives

To characterize the pharmacokinetics of LB1908 in blood

To evaluate the immunogenicity of LB1908

To evaluate the preliminary efficacy of LB1908

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: Experimental LB1908Experimental Treatment1 Intervention

Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells

Do I qualify?Apply below to find out

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

The most common treatments for stomach cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies, such as those involving HER2 inhibitors, focus on specific molecular targets associated with cancer growth. Immunotherapy, including CAR T-cell therapy, represents a more recent advancement. CAR T-cell therapy involves genetically engineering a patient's T-cells to express receptors that specifically target antigens on cancer cells, such as Claudin 18.2. This approach enhances the immune system's ability to recognize and destroy cancer cells. For stomach cancer patients, these targeted treatments are crucial as they offer more personalized and potentially more effective options, especially for those with advanced or treatment-resistant forms of the disease.

MSLN (Mesothelin), ANTXR1 (TEM8), and MUC3A are the potent antigenic targets for CAR T cell therapy of gastric adenocarcinoma.Upregulation of bone morphogenetic protein 1 is associated with poor prognosis of late-stage gastric Cancer patients.