Cell Therapy for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells.Objective:To see if gene transfer is safe and causes tumors to shrink.Eligibility:People at least 18 years old with certain kidney cancerDesign:Participants will be screened with blood and urine tests. They may have:* Scans* Heart, lung, and eye tests* Lab tests* Tumor samples takenParticipants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant s other arm.Participants cells will be grown in the lab and genetically changed.Participants will stay in the hospital 2-3 weeks. There they will:* Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest.* Get the changed cells via catheter.* Get a drug to increase white blood cell count and one to make the cells active.* Recover for about a week.* Have lab and blood tests.After leaving the hospital, participants will:* Take an antibiotic for several months.* Have leukapheresis.* Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam.Participants will have follow-up checks for up to 15 years.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain cancer treatments like anti-VEGFR therapy or mTOR inhibitors for at least 7 days before the T-cell infusion, and PD-1/PD-L1 or CTLA-4 inhibitors for 4 weeks before the infusion.
Is cell therapy for kidney cancer safe for humans?
How does the Cell Infusion treatment for kidney cancer differ from other treatments?
Cell Infusion for kidney cancer is unique because it involves using the patient's own immune cells, specifically tumor-infiltrating lymphocytes (TIL), which are cultivated and activated outside the body before being infused back into the patient. This approach aims to harness the body's immune system to target and destroy cancer cells, offering a novel alternative to traditional treatments like surgery, chemotherapy, and radiation, which are often less effective for this condition.678910
What data supports the effectiveness of the treatment Cell Infusion for kidney cancer?
Who Is on the Research Team?
Richard W Childs, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of HERV-E TCR transduced CD8+/CD34+ enriched T-cells and IL-2 administration
Follow-up
Participants are monitored for safety and effectiveness after treatment, with clinic visits every few weeks for 2 years, and then as determined by their doctor
Long-term follow-up
Participants will have follow-up checks for up to 15 years to monitor long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Cell Infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
Loyola University Medical Center (LUMC)
Collaborator