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CAR T-cell Therapy
CD70-Targeted CAR T-cell Therapy for Cancer
Phase 1 & 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
Age greater than or equal to 18 years and less than or equal to 72 years
Clinical performance status of ECOG 0 or 1
Must not have
Concurrent systemic steroid therapy
History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion
Awards & highlights
Summary
This trial is testing a new cancer therapy in which a person's white blood cells are modified with anti-CD70 before being given back to the person. The aim is to see if this can safely shrink tumors.
Who is the study for?
Adults aged 18-72 with CD70-expressing cancers like kidney, breast, or ovarian cancer who've tried at least one standard treatment without success. They must have a certain level of blood cells and organ function, not be pregnant or breastfeeding, HIV negative, and willing to use birth control.
What is being tested?
The trial tests gene transfer therapy using modified white blood cells targeting CD70 on cancer cells. It includes chemotherapy drugs (cyclophosphamide and fludarabine) and aldesleukin before infusing the engineered cells. Participants will be monitored regularly for tumor response and safety.
What are the potential side effects?
Possible side effects include reactions to cell infusion, effects from chemotherapy like nausea or hair loss, increased infection risk due to immune system changes, fatigue, bleeding complications from low platelet counts, liver enzyme elevation indicating potential liver damage.
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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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer cannot be removed by surgery and tests show it has a high level of CD70.
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My cancer is visible on scans, can't be surgically removed, and tests high for CD70.
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I have finished all my previous cancer treatments.
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My white blood cell count is healthy without needing medication.
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I have tried at least one standard cancer treatment and it did not work or my cancer came back.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on systemic steroid therapy.
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I have an autoimmune disease that needs treatment to suppress my immune system.
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I do not have any active infections, bleeding disorders, or major illnesses that are not under control.
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I have had heart surgery or symptoms of reduced blood flow to my heart.
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I have a primary immunodeficiency disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MTD of anti-hCD70 CAR transduced PBL + high-dose aldesleukin
Group II: 1/Phase IExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + escalating doses of anti-hCD70 CAR transduced PBL + high-dose aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine
2012
Completed Phase 4
~1860
Aldesleukin
2012
Completed Phase 4
~1620
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,876 Total Patients Enrolled
290 Trials studying Ovarian Cancer
74,817 Patients Enrolled for Ovarian Cancer
James C Yang, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
408 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have up to 3 small, symptom-free brain tumors or have had brain surgery.I am between 18 and 72 years old.I am fully active or restricted in physically strenuous activity but can do light work.You do not have hepatitis B or C. If you test positive for hepatitis C, you need to have another test to make sure the virus is not in your blood.Your total bilirubin level is less than 2.0 mg/dL, unless you have Gilbert's Syndrome, in which case it should be less than 3.0 mg/dL.Participants must be enrolled in a specific cell harvest protocol alongside this study.I am currently on systemic steroid therapy.My cancer cannot be removed by surgery and tests show it has a high level of CD70.My cancer is visible on scans, can't be surgically removed, and tests high for CD70.I have an autoimmune disease that needs treatment to suppress my immune system.You've had a serious allergic reaction to cyclophosphamide, fludarabine, or aldesleukin in the past.I do not have any active infections, bleeding disorders, or major illnesses that are not under control.I have finished all my previous cancer treatments.I do not have any current infections that could weaken my immune system.You are currently taking any other experimental medications.My white blood cell count is healthy without needing medication.I have had heart surgery or symptoms of reduced blood flow to my heart.If you have a history of heart problems and your heart's ability to pump blood is less than or equal to 45%.My hemoglobin level is above 8.0 g/dL, possibly after a transfusion.Your platelet count should be 80,000/mm(3) or more.Your white blood cell count is 2500/mm(3) or higher.If you have a history of lung problems and your FEV1 test shows that your lung function is less than 50% of what is expected for someone your age and size, you may not be able to participate.Your cancer diagnosis needs to be confirmed by the NCI Laboratory of Pathology.I have a primary immunodeficiency disorder.I have tried at least one standard cancer treatment and it did not work or my cancer came back.I agree to use birth control during and for four months after the study.You do not have HIV, a virus that affects the immune system. This is because the experimental treatment works best in people with a strong immune system.Your liver enzymes (ALT/AST) levels in the blood are within a certain range.Your blood creatinine level is less than or equal to 1.6 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: 2/Phase II
- Group 2: 1/Phase I
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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