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Genetically-Engineered Immune Cells for Lung Cancer (CheckCell-2 Trial)
CheckCell-2 Trial Summary
This trial is testing a new way to treat lung cancer using genetically-engineered immune cells. The goal is to see if this new treatment is safe and effective.
CheckCell-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCheckCell-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CheckCell-2 Trial Design
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Who is running the clinical trial?
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- I have a health condition that may make it hard for me to handle strong cancer treatment.I agree to stay near the treatment site until the 4-week follow-up.I have had serious lung inflammation or currently have lung disease needing steroids.I am currently dealing with an opportunistic infection.My lung cancer is confirmed as non-small cell type, with any PD-L1 status.Your blood test results from the past 3 months meet certain requirements.You have a condition that weakens your immune system from birth.I have had another type of cancer in the last 3 years.I agree to use effective birth control.I am mostly active and my doctors believe I have 6 or more months to live.I am eligible for or started anti-PD-1/PD-L1 and chemotherapy within the last 6 months (Phase 1) or 3 months (Phase 2).I have at least one tumor that can be surgically removed and another that can be measured.I have not taken steroids recently.I do not have any active infections, bleeding disorders, or serious illnesses.I haven't received any live vaccines in the last 28 days.My organs are functioning well enough for me to join the study.My cancer has a mutation that responds to specific approved treatments.I have a history of heart problems.Your heart is not pumping blood effectively, as measured by a test called LVEF, which is less than 45%.Your blood test results from the past 14 days meet certain standards.I haven't had cell therapy or an organ transplant in the last 20 years.I am between 18 and 70 years old.Your white blood cell count is at least 3000 per cubic millimeter.Your platelet count is at least 75,000 per cubic millimeter.My lung cancer is confirmed as non-small cell type, with any PD-L1 status.
- Group 1: CISH CRISPR TIL / Phase II Arm PD-L1 Negative Cohort
- Group 2: CISH CRISPR TIL / Phase II Arm PD-L1 Positive Cohort
- Group 3: CISH CRISPR TIL / Phase I Arm
- Group 4: CISH CRISPR TIL plus pembrolizumab / Phase I Arm
- 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
Does your research include individuals aged 55 or older?
"This research project is open to individuals aged 18 and over, up until the age of 75."
What criteria must one meet to partake in this clinical examination?
"This clinical trial is recruiting 70 individuals diagnosed with squamous cell carcinoma between the ages of 18 and 75. Applicants must meet a number of criteria, such as having confirmed histologic diagnosis for metastatic NSCLC (PD-L1 negative or positive) that can be treated with anti-PD-1/anti-PD-L1 immunotherapy plus chemotherapy, measurable disease per RECIST version 1.1., ECOG performance status 0 or 1, and more. Patients who have already started first line treatment are also eligible under certain conditions outlined in the requirements list."
Are new participants welcome to join this research endeavor?
"Data hosted on clinicaltrials.gov reveals that, as of September 30th 2022, this particular research trial has ceased its recruitment activities; it was initially posted to the website in November 1st 2022. Fortunately, there are 1946 other medical studies actively enrolling patients at the moment."
What are the key aims of this investigation?
"Intima Bioscience, Inc., the study sponsor has set a 3.5 year timeline to evaluate Phase 1 Safety and Initial Efficacy as their primary objective. Toxicity incidence, overall survival (Kaplan-Meier estimate), and duration of response are all secondary outcomes that will be measured by researchers during this period."
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