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CAR T-cell Therapy
T Cell Immunotherapy for Lung Cancer
Phase 2
Recruiting
Led By James C Yang, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have completed any prior systemic therapy at the time of enrollment
Age between 18 and 72 years
Must not have
Active systemic infections, coagulation disorders, or any other active or uncompensated major medical illnesses
Ongoing need for pharmacological immunosuppression, including steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 years post cell infusion
Awards & highlights
Summary
This trial is testing an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Who is the study for?
Adults aged 18-72 with advanced non-small cell lung cancer (NSCLC) who've had prior treatment and have a tumor that can be removed. They must not have HIV, active hepatitis B or C, and agree to use birth control. Excluded are those on other trials, breastfeeding women, people needing steroids, with major medical issues, severe allergies to study drugs or certain heart/lung conditions.
What is being tested?
The trial is testing Tumor Infiltrating Lymphocytes (TIL) therapy in NSCLC patients. This involves removing the patient's tumor cells, growing specific white blood cells from them in a lab and infusing them back into the patient along with chemotherapy drugs Cyclophosphamide and Fludarabine followed by Aldesleukin.
What are the potential side effects?
Possible side effects include reactions to cell infusion like fever or chills; effects of chemotherapy such as nausea, hair loss; immune reactions affecting organs; fatigue from Aldesleukin; increased risk of infection due to lowered white blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have finished all my previous cancer treatments.
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I am between 18 and 72 years old.
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My lung cancer is advanced but has a part that can be removed for treatment.
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I have up to 3 small brain tumors (under 1 cm) that don't cause symptoms, or they've been treated and are stable.
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I am fully active or can carry out light work.
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I have had at least one treatment for my condition and it has gotten worse.
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I am a woman who can have children and have a negative pregnancy test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any active infections, bleeding disorders, or serious illnesses.
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I am currently taking medication to suppress my immune system.
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I have a severe blockage or bleeding in my airways that can't be relieved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 years post cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 years post cell infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response rate
Secondary study objectives
Frequency and severity of treatment-related adverse events
Phenotypic and functional characteristics of TIL
Side effects data
From 2010 Phase 4 trial • 26 Patients • NCT0041476529%
Atrial fibrillation
14%
Sepsis
14%
Renal failure
14%
International normalised ratio increased
14%
Oliguria
14%
Mental status changes
14%
Chronic obstructive pulmonary disease
14%
Dyspnoea
14%
Respiratory failure
14%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
mRCC
Metastatic Melanoma
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Low-Dose AldesleukinExperimental Treatment4 Interventions
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine plus young TIL plus low-dose Aldesleukin
Group II: 1/High-Dose AldesleukinExperimental Treatment4 Interventions
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine plus young TIL plus high-dose Aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Young TIL
2012
Completed Phase 2
~70
Aldesleukin
2012
Completed Phase 4
~1620
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2320
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,915 Total Patients Enrolled
James C Yang, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
447 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that weakens your immune system from birth.I am willing to use birth control during and after my treatment.I do not have any active infections, bleeding disorders, or serious illnesses.Your blood counts need to be within normal ranges: ANC (a type of white blood cell) should be higher than 1000, WBC (white blood cell) count should be higher than 2500, Hb (hemoglobin) should be higher than 8.0, and platelet count should be higher than 80,000.I am between 18 and 72 years old.You have an ongoing opportunistic infection.Your heart's pumping function (LVEF) is below 45%.You are currently taking any other experimental drugs.My lung cancer is advanced but has a part that can be removed for treatment.I have up to 3 small brain tumors (under 1 cm) that don't cause symptoms, or they've been treated and are stable.It has been over two weeks since I received treatment for major airway blockage or bleeding.I have finished all my previous cancer treatments.I am currently taking medication to suppress my immune system.I am over 66, have had more than 2 chest surgeries, or have poor exercise tolerance.I have a severe blockage or bleeding in my airways that can't be relieved.I am fully active or can carry out light work.Your liver and kidney function tests need to be within certain limits: ALT/AST levels in the blood should be no more than 2.5 times the normal range, creatinine levels should be no more than 1.6 mg/dl, and total bilirubin should be no more than 2 mg/dl (or 3 mg/dl if you have Gilbert's Syndrome).I have had at least one treatment for my condition and it has gotten worse.You do not have HIV, active hepatitis B, or hepatitis C.I am a woman who can have children and have a negative pregnancy test.If you have a history of lung problems, your FEV1 (a measure of lung function) is less than 50%.
Research Study Groups:
This trial has the following groups:- Group 1: 2/Low-Dose Aldesleukin
- Group 2: 1/High-Dose Aldesleukin
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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