Cell Therapy for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called gene transfer for kidney cancer. The process involves taking a person's white blood cells, modifying them in a lab to attack cancer cells, and then reintroducing them into the body to assess tumor shrinkage and safety. Known as cell infusion (a type of cell therapy), this treatment targets individuals with certain types of kidney cancer that have progressed despite previous treatments. Participants will undergo several procedures, including blood cell collection and hospital stays for treatment and recovery. Ideal candidates have been diagnosed with specific kidney cancer, have experienced disease progression, and can tolerate a hospital stay. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a new gene therapy using modified T-cells, called HERV-E TCR transduced T-cells, has been tested in people with kidney cancer. In one study, patients with advanced kidney cancer received these specially altered T-cells along with a moderate dose of IL-2, a drug that helps the T-cells survive and function better.
The study aimed to understand the side effects of this treatment. Some patients experienced side effects, but they were generally manageable. For instance, IL-2 can cause flu-like symptoms, such as fever and chills, in some patients. However, there were no reports of severe or life-threatening issues directly linked to the T-cell treatment.
This trial is in its early stages, focusing mainly on safety. Early trials usually involve small groups of people to closely monitor any risks. Until more information becomes available, participants should discuss the potential risks and benefits with their doctors.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the cell therapy for metastatic clear cell renal cell carcinoma because it represents a novel approach that differs significantly from standard treatments like targeted therapy, immunotherapy, and surgery. Unlike these conventional methods, this therapy involves the infusion of genetically modified T-cells that are engineered to target and attack cancer cells more precisely. The treatment uses HERV-E TCR transduced CD8+/CD34+ enriched T-cells, which are a new type of engineered immune cell designed to enhance the body's natural ability to fight cancer. This targeted action could potentially lead to more effective tumor eradication with fewer side effects. Additionally, the use of IL-2 to boost the immune response after cell infusion offers another layer of innovation, potentially improving treatment outcomes.
What evidence suggests that this trial's treatments could be effective for kidney cancer?
Research has shown that a new type of modified immune cell, called HERV-E TCR transduced T-cells, may help treat kidney cancer, particularly clear cell renal cell carcinoma. In earlier studies, researchers designed these modified cells to find and destroy cancer cells by recognizing a specific protein on the tumor. Early results suggested that this method can shrink tumors. In this trial, participants will receive varying levels of HERV-E TCR transduced T-cells to evaluate their effectiveness. Although more research is needed, these initial findings offer hope for a new way to combat this cancer.23456
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