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CAR T-cell Therapy
Cell Therapy for Kidney Cancer
Phase 1
Waitlist Available
Led By Richard W Childs, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically confirmed RCC with clear-cell component by the Laboratory of Pathology of the NIH and/or outside Pathology Department prior to entering this study.
Patients must be between the ages of 18 and 75 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights
Study Summary
This trial is testing a new cancer therapy that takes white blood cells from a person, grows them in a lab, and changes them with a virus to attack tumor cells. The objective is to see if gene transfer is safe and causes tumors to shrink. Eligible participants are people at least 18 years old with certain kidney cancer. The trial involves several hospital stays and clinic visits over the course of 2 years, with follow-up checks for up to 15 years.
Who is the study for?
Adults aged 18-75 with certain types of kidney cancer, who have tried at least one antiangiogenic drug and an immune-checkpoint inhibitor. They must not be HIV or hepatitis positive, have a life expectancy over 3 months, agree to use contraception, and have someone to care for them during the first month post-treatment.Check my eligibility
What is being tested?
The trial is testing gene transfer therapy where patients' white blood cells are modified in a lab to fight kidney cancer. This involves leukapheresis (blood filtration), chemotherapy drugs, cell modification, reinfusion of changed cells into the patient's body, and follow-up visits for up to 15 years.See study design
What are the potential side effects?
Potential side effects include reactions from chemotherapy such as nausea and fatigue; risks associated with leukapheresis like dizziness or fainting; possible inflammation due to cell infusion; and general risks from immunotherapy including fever or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer diagnosis was confirmed by a pathology lab.
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I am between 18 and 75 years old.
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My genetic test shows I am HLA-A 11:01 positive.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have hepatitis B or C, or if I had hepatitis C, it's no longer active.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ongoing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity
Secondary outcome measures
overall response rate
overall survival
progression-free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
This is a single-arm, phase 1 trial of HERV-E TCR transduced CD8+/CD34+ T cells in HLA-A*11:01 positive patients with metastatic ccRCC. The study is planned based on a Phase 1 3+3 dose escalation design. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a dose limiting toxicity (DLT).
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,843 Previous Clinical Trials
47,817,092 Total Patients Enrolled
Loyola University Medical Center (LUMC)UNKNOWN
Richard W Childs, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
18 Previous Clinical Trials
8,740 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a severe reaction to immunotherapy that needed long-term treatment, but not for vitiligo or hypothyroidism.I have been treated with drugs that target blood vessel growth and immune system checkpoints, unless I couldn't for health, availability, or personal reasons.I have someone who can stay with me during the first month of my treatment.I have clear cell RCC and no other cancer needing treatment in the last 4 years, except for certain skin, cervical, or breast cancers.I can understand the study details and can give informed consent, or I have someone who can do it on my behalf.You must not have HIV. The treatment being studied works best in people with a strong immune system.I need urgent treatment because my tumor is pressing on my spine or other organs.I haven't had certain cancer treatments or major surgery recently.My brain cancer is stable, treated, or surgically removed with no active disease now.My calcium levels are high due to cancer.I haven't taken high doses of steroids in the last 2 days, except for allowed types and reasons.I am between 18 and 75 years old.Your liver and kidney function tests need to be within normal limits, and your blood clotting time should be normal.My kidney cancer diagnosis was confirmed by a pathology lab.I have been on a stable dose of bisphosphonates or denosumab for at least 4 weeks.Your heart is pumping blood effectively, with an ejection fraction of 45% or higher, as measured by an echocardiogram.My genetic test shows I am HLA-A 11:01 positive.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has grown or spread after my last treatment and within the past 6 months.I have an autoimmune disease and need ongoing treatment to suppress my immune system.I do not have hepatitis B or C, or if I had hepatitis C, it's no longer active.I do not have major uncontrolled illnesses or infections.Your lung function test results show that your lungs are working at least 45% as well as they should be.Your blood test shows that you have enough white blood cells, neutrophils, and platelets.I have a condition that significantly weakens my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: 1
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open enrollment spots for this trial?
"This medical trial is actively seeking volunteers, with the initial posting made on July 20th 2018 and an update provided in September 28th 2022."
Answered by AI
Is participation in this scientific exploration open to me?
"Candidates must be between 18 and 75 years old, present with carcinoma or renal cell, and have not exceeded 24 recruits. These are the criteria for admission to this medical trial."
Answered by AI
To what extent has recruitment been successful for this trial?
"Affirmative, the clinicaltrials.gov database indicates that this medical study is actively recruiting patients. This trial was initiated on July 20th 2018 and underwent its most recent update on September 28th 2022; 24 participants are required from one particular site."
Answered by AI
Is this trial accommodating individuals who have exceeded the 60-year threshold?
"This clinical trial is only open to people aged 18-75. For those below the age of consent, there are 31 studies available, while 409 exist for seniors over 65 years old."
Answered by AI
What dangers must be considered when administering cell infusion treatments?
"With only basic data confirming cell infusion's efficacy and safety, it is assigned a score of 1 on the Power team's scale."
Answered by AI
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