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CT041 CAR-T Therapy for Stomach and Pancreatic Cancer
Study Summary
This trial is testing a new treatment for stomach, pancreatic, and other digestive system cancers using CAR-T cells, which are immune cells that are genetically modified to target and kill cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your doctor thinks you will live for more than 4 months.I need blood-thinning medication like warfarin or heparin.I have another type of cancer besides stomach or pancreatic cancer.My blood, kidney, and liver tests are within normal ranges.I am fully active or can carry out light work.You have at least one visible and measurable abnormality according to specific guidelines.My cancer has significantly affected my lungs.I am unable or unwilling to follow the clinical trial requirements.I have a serious lung condition.You have a current autoimmune disease that is not under control.I am not allergic to the drugs used before and during my treatment, including tocilizumab and DMSO.I have not responded well to previous cancer treatments.I still have side effects from my previous cancer treatment.I have an active stomach ulcer or recent stomach surgery that could cause bleeding.I have had cellular therapy or an organ transplant.I am a man and willing to use contraception for at least 12 months after T-cell infusion.You have good nutrition and are healthy.I can undergo leukapheresis with no issues.I have a serious thyroid problem.I haven't taken prednisone or similar drugs in the last 14 days.I haven't had cancer treatment in the last 2 weeks before my cell collection or before preconditioning.I am not pregnant and agree to use birth control during the study.I am between 18 and 75 years old with a confirmed diagnosis of stomach or pancreatic cancer.I need to take medication long-term to prevent blood clots.My cancer has spread to my brain or spinal cord and hasn't been treated.My tumor is CLDN18.2 positive.I do not have active HIV, hepatitis B, or hepatitis C.I do not have any ongoing infections that aren't being treated.You have severe neurological disorders.I have not had major surgery within the last week before leukapheresis or within 3 weeks before preconditioning.
- Group 1: anti-claudin18.2 chimeric antigen receptor T-cell therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Who might be the ideal candidates for enrollment in this clinical trial?
"This clinical trial seeks 110 individuals, aged 18 to 76 years old, who have been clinically diagnosed with malignant neoplasm of the pancreas. Other prerequisites include being able to voluntarily sign an Informed Consent Form (ICF), having failed or experienced intolerance from prior systemic therapies and expectancy for survival exceeding 4 months. The participants should also be ECOG performance status 0-1; possess sufficient venous access for leukapheresis collection and normal CBC counts, renal functions and liver functioning. For female candidates within childbearing age group must obtain a negative serum pregnancy test result before screening/infusion and agree to use reliable"
Are any participants being accepted for this research initiative presently?
"Affirmative, according to clinicaltrials.gov, the trial is still recruiting patients since it was first published in October 2020 and last updated on August 8th 2022. 110 participants are needed from 21 sites across the country."
What is the highest capacity for enrollment in this clinical trial?
"In order to fulfil the scientific requirements of this trial, 110 qualified participants are needed. Patients can join from various locations around the United States such as Mayo Clinic - AZ in Phoenix and The Mount Sinai Hospital in New york City."
What is the major goal of this clinical trial?
"During the 28-day period of this clinical trial, its primary outcome will be to measure Treatment Related Adverse Events (AEs). Secondary outcomes include a Rate of subjects experiencing >/= Partial Response per RECIST 1.1 as determined by investigator; Persistence of CAR transgene copy number in PK and bio-distribution profiles; and Objective Response Rate (ORR), which is measured through the rate of subjects exhibiting >/= Partial Response per RECIST 1.1 as determined by Investigator."
How many sites have been designated to conduct this research?
"At this moment in time, 21 medical facilities are running the trial. These sites can be found in Phoenix, New york and New Hyde Park amongst other cities. To reduce travel needs it is suggested that participants select a location close to them if they do join."
Does this experiment include geriatric individuals?
"Participants must be aged between 18 and 76 to take part in this research."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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