CCR4 CAR T Cells for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the safety of a new gene therapy for certain mature T-cell lymphomas that haven't responded to other treatments. The therapy, called Autologous CCR4 CAR T cells, uses a patient's own white blood cells, modified to attack cancer cells with a specific protein called CCR4. People with T-cell lymphomas that have the CCR4 protein and who haven't seen success with previous treatments might be a good fit for this study. As a Phase 1 trial, the research focuses on understanding 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 need to stop taking your current medications. However, you cannot take any investigational agents or certain cancer treatments close to the start of the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that CAR T cells, including the CCR4 CAR T cells under study, have been used safely in other types of cancer. In previous studies with similar treatments, many patients experienced positive outcomes. However, some side effects, such as fever and low blood pressure, were reported and are common with this kind of therapy.
The treatment involves modifying a person's own white blood cells to help fight cancer. This approach has successfully treated some cancers that did not respond to other treatments. As a Phase 1 trial, this study primarily focuses on testing the treatment's safety. Researchers are still learning about its tolerability and potential side effects. Participants will receive close monitoring throughout the trial to ensure their safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about autologous CCR4 CAR T cells for T-cell lymphoma because this treatment offers a novel approach by genetically modifying a patient's own immune cells to specifically target and destroy cancer cells expressing the CCR4 protein. Unlike traditional chemotherapy or radiation, which can harm both healthy and cancerous cells, this CAR T-cell therapy aims to provide a more precise attack on the lymphoma cells, potentially reducing side effects and improving effectiveness. Additionally, this treatment involves escalating doses and determining the maximum tolerated dose, which could optimize the balance between efficacy and safety.
What evidence suggests that this treatment might be an effective treatment for T-cell lymphoma?
Research has shown that a new treatment using CCR4 CAR T cells could be promising for T-cell lymphomas, a type of cancer. In this trial, participants will receive conditioning chemotherapy with cyclophosphamide and fludarabine, followed by autologous CCR4 CAR T-cells. These specially modified white blood cells can find and attack cancer cells with the CCR4 protein. In past studies, 40% to 74% of patients with similar cancers experienced complete remission. This treatment harnesses the body's own immune system, reprogramming its cells to target the cancer, which is why researchers remain hopeful about its potential.36789
Who Is on the Research Team?
Samuel Y Ng, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for adults with certain mature T-cell lymphomas that express CCR4 and have not improved or returned after treatment. Participants must be over 18, have a specific type of T-cell lymphoma, and undergo screening tests including blood, urine, heart and lung function tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Cell Modification
Leukapheresis is performed to obtain T-cells, which are then genetically modified to express anti-CCR4 CARs
Conditioning Chemotherapy
Participants receive conditioning chemotherapy with cyclophosphamide and fludarabine to prepare the body for CAR T-cell infusion
CAR T-cell Infusion
Infusion of autologous CCR4 CAR T-cells at escalating doses
Initial Monitoring
Participants are monitored for toxicity, antitumor effects, and persistence of CCR4 CAR T-cells
Follow-up
Participants are monitored for safety and effectiveness after treatment, with periodic imaging and laboratory testing
What Are the Treatments Tested in This Trial?
Interventions
- Autologous CCR4 CAR T cells
Trial Overview
The study is testing the safety of gene therapy using patients' own white blood cells modified to target cancer cells with anti-CCR4 CAR (chimeric antigen receptors). It involves leukapheresis to collect T-cells, chemotherapy preparation, then infusion of the engineered CAR T-cells.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Conditioning chemotherapy with cyclophosphamide and fludarabine followed by autologous CCR4 CAR T-cells (IV) at the MTD
Conditioning chemotherapy with cyclophosphamide and fludarabine followed by autologous CCR4 CAR T-cells (IV) at escalating doses
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Identifying highly active anti-CCR4 CAR T cells for the ...
In summary, CCR4–depleted anti-CCR4 CAR T cells are enriched in Th1 and CD8+ T cells and exhibit high antitumor efficacy against CCR4–expressing T-cell ...
Long-term outcomes following CAR T cell therapy
In the multicentre trials that followed, complete response (CR) rates of 40–54%, 67% and 69–74% were observed in patients with R/R aggressive B ...
CAR T-cell therapies for T-cell malignancies: does cellular ...
In this review we discuss the current state of CAR-T treatment for T-ALL and T cell lymphomas, highlighting recent novel clinical data for T cell malignancies.
Long-term outcomes of CAR-T cell therapy in DLBCL.
Efficacy: Complete remission occurred in 59% with a median response duration of 8.3 months. Safety profile: CRS occurred in 100% of patients, ...
Advances in CAR-T-cell therapy in T-cell malignancies
These findings indicate that CD5 CAR-T-cell therapy can safely elicit clinical responses in patients with CD5-positive T-cell lymphomas without ...
Long-term outcomes following CAR T cell therapy
These CAR T cells have also generated CR rates of 71–81% in multicentre clinical trials involving patients with R/R B cell acute lymphoblastic ...
the long-term safety of autologous chimeric antigen ...
Engineering a patient's own T cells to express chimeric antigen receptors (CARs) has cured patients with cancer refractory to all treatments.
NCT07055477 | A Phase I Trial Anti-CC Chemokine ...
The CAR in this study attacks the CCR4 protein found on your T-cell lymphoma. This type if therapy is called gene therapy. Gene therapy involves a person s own ...
Impact of T cell characteristics on CAR-T cell therapy in ...
In addition, rates of unsuccessful CAR-T cell manufacture are approximately 25% for non-Hodgkin's lymphoma (NHL) patients, and 6.8% for B-ALL ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.