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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
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
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental LB1908Experimental Treatment1 Intervention
Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells
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.
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.
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Who is running the clinical trial?
Legend Biotech USA IncLead Sponsor
2 Previous Clinical Trials
91 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need blood thinners like warfarin or heparin.I have another type of cancer that doesn't meet the study's exceptions.I do not have an active HIV, hepatitis B, or hepatitis C infection.I have been treated with claudin 18.2-targeted therapy before.My cancer in the stomach, GEJ, or lower esophagus cannot be surgically removed and standard treatments are not suitable for me.My organs are functioning well.I have previously received cellular immunotherapy or gene therapy.I need to take medication long-term to prevent blood clots.I am not allergic to LB1908, fludarabine, cyclophosphamide, or tocilizumab.I have cancer that has spread to my brain or the lining around my brain.My cancer has spread significantly to my lungs or liver.I am between 18 and 75 years old.I have had or am preparing for an organ or stem cell transplant.I am fully active or can carry out light work.My heart does not function properly due to a significant condition.I have advanced pancreatic cancer and cannot or choose not to undergo standard treatment.My tumor is CLDN18.2 positive with significant staining.I have received previous treatments as required.My side effects from cancer treatment are mild, except for hair loss, tiredness, nausea, or constipation.I need weekly treatment for fluid buildup in my abdomen or chest.My stomach or esophagus cancer was treated with specific chemotherapy, and if HER2 positive, also with anti-HER2 therapy.I had surgery on my esophagus or stomach and am at risk of bleeding or perforation.I am taking immunosuppressants for an autoimmune disease.I received cancer treatment before apheresis within the specified time.I agree not to donate eggs or sperm for 1 year after my LB1908 infusion.I haven't had major surgery in the last 4 weeks and don't plan to have any in the next 4 weeks.My pancreatic cancer was treated with fluoropyrimidine or gemcitabine.I am a woman who can have children and my pregnancy test was negative.I don't have active ulcers, varices, bleeding in my digestive tract, or recent digestive surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental LB1908
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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