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CAR T-cell Therapy
Immunotherapy with TIL for Cancer
Phase 2
Recruiting
Led By Steven A Rosenberg, 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
Age between 18 and 72 years
Measurable metastatic cancer of specific types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors
Must not have
Active systemic infections, coagulation disorders, or any other active or uncompensated major medical illnesses
Known FEV1 less than or equal to 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose
Awards & highlights
Summary
This trial is testing a new experimental therapy to see if it can cause tumors to shrink in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. The therapy involves taking white blood cells from patients' tumors, growing them in the laboratory, and then giving the cells back to the patient.
Who is the study for?
Adults aged 18-72 with certain types of metastatic cancer (digestive tract, breast, ovarian/endometrial, etc.) who haven't responded to standard treatments. Participants must not have HIV or hepatitis, agree to birth control and testing if applicable, and be in relatively good health otherwise.
What is being tested?
The trial is testing a therapy where white blood cells from the patient's tumor are grown in large numbers and reinfused into them. The study aims to see if these Tumor Infiltrating Lymphocytes (TIL) can shrink tumors effectively and safely.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the cell transfer process, fatigue due to high cell growth activity, and complications from chemotherapy drugs used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 72 years old.
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My cancer is metastatic and falls into one of the specified categories.
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I have up to 3 small, symptom-free brain tumors.
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My cancer did not respond to standard treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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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My lung function (FEV1) is 50% or less.
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I do not have any current infections.
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I have had heart surgery or symptoms of reduced blood flow to my heart.
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My liver function score is moderate to severe due to my liver cancer.
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I have an autoimmune disease affecting a major organ.
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I am currently pregnant or breastfeeding.
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My advanced cancer is causing blockage, risk of hole formation, or bleeding that requires blood transfusions.
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I have had severe side effects from anti-PD-1/PD-L1 cancer therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose
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
Safety and efficacy of pembrolizumab in combination with TIL therapy
Trial Design
4Treatment groups
Experimental Treatment
Group I: 4/Unselected TIL + Pembro at PODExperimental Treatment5 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin + pembrolizumab within 4 weeks of progressive disease for up to 8 doses every 3 weeks
Group II: 3/Unselected TIL + Pembro Prior to CellsExperimental Treatment5 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin + pembrolizumab prior to cell administration and 3 additional doses every 3 weeks following cell infusion
Group III: 2/Unselected TIL (CLOSED)Experimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin (CLOSED)
Group IV: 1/CD8+ Enriched TIL (CLOSED)Experimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young CD8+ enriched TIL + high-dose aldesleukin (CLOSED)
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
Cyclophosphamide
2010
Completed Phase 4
~2320
Pembrolizumab (Keytruda)
2020
Completed Phase 1
~10
Fludarabine
2012
Completed Phase 4
~1860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,668 Total Patients Enrolled
291 Trials studying Ovarian Cancer
74,941 Patients Enrolled for Ovarian Cancer
Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)
37 Previous Clinical Trials
17,549 Total Patients Enrolled
5 Trials studying Ovarian Cancer
496 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 72 years old.You do not have HIV, hepatitis B, or hepatitis C in your blood.Certain blood and chemistry test results must meet specific requirements.I do not have any active infections, bleeding disorders, or serious illnesses.My lung function (FEV1) is 50% or less.I am on steroids, but only because my brain cancer requires it.You have had a serious allergic reaction to certain medications in the past.I do not have any current infections.I have had heart surgery or symptoms of reduced blood flow to my heart.My liver function score is moderate to severe due to my liver cancer.I have an autoimmune disease affecting a major organ.My cancer is metastatic and falls into one of the specified categories.I have up to 3 small, symptom-free brain tumors.My cancer did not respond to standard treatments.I am fully active or restricted in physically strenuous activity but can do light work.I am currently pregnant or breastfeeding.My advanced cancer is causing blockage, risk of hole formation, or bleeding that requires blood transfusions.I have had severe side effects from anti-PD-1/PD-L1 cancer therapy.Your diagnosis of cancer that has spread has been confirmed by the NCI Laboratory of Pathology.You have a condition that weakens your immune system from birth.
Research Study Groups:
This trial has the following groups:- Group 1: 4/Unselected TIL + Pembro at POD
- Group 2: 2/Unselected TIL (CLOSED)
- Group 3: 1/CD8+ Enriched TIL (CLOSED)
- Group 4: 3/Unselected TIL + Pembro Prior to Cells
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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