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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
Study Summary
This trial is testing a new cancer therapy on people with advanced stomach, esophagus & pancreas cancer.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 25 and above eligible to enroll in this experiment?
"The trial's eligibility requirements have set 18 years of age as the minimum and 75 years old as the maximum for participation."
Answered by AI
Has the FDA sanctioned Experimental LB1908 for public use?
"Our team at Power estimates that Experimental LB1908 is relatively safe, scoring a 1 on our scale. This assessment is based on the limited evidence of the drug's efficacy and safety due to it still being in its first stage of trials."
Answered by AI
Is enrollment to this trial still open for potential participants?
"This research project, originally published on April 18th 2023 and updated just recently, is currently open for enrollment. The data hosted at clinicaltrials.gov affirms this fact."
Answered by AI
Is it possible for me to enroll in this research project?
"This research seeks 56 patients aged 18 to 75 with esophageal cancer. Essential qualifications include having normal organ function."
Answered by AI
How extensive is the participation in this experiment?
"Affirmative. Hosted information on clinicaltrials.gov indicates that patient recruitment for this medical research is in progress, with the trial having been first posted and last updated on April 18th 2023. In total, 2 sites will be enrolling 56 participants."
Answered by AI
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