CAR T Cell Therapy for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with aggressive brain cancer that has returned or worsened. The treatment employs a special type of immune cell, called CAR T cells (Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells), modified to recognize and attack cancer cells in the brain. The main goal is to determine the safest dose and understand any side effects. This trial may suit someone who has had glioblastoma or a similar brain tumor and whose cancer has progressed after standard treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on active bevacizumab therapy, you cannot participate in the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the EGFR/IL13Rα2 pool-CAR T cell therapy is undergoing testing for safety when administered directly into the brain. Studies suggest that this delivery method is safe and feasible. Previous trials in brain cancer patients indicate that the treatment can be administered safely. However, similar CAR T cell therapies have reported serious side effects, including low blood pressure and fluid buildup in the lungs. As this is an early-stage trial, the treatment's safety remains under careful study. Participants should discuss these potential risks with their healthcare provider.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, CAR T cell therapy offers a novel approach by using engineered immune cells to target cancer. This treatment is unique because it specifically targets EGFR and IL13Rα2, proteins commonly found on the surface of brain cancer cells, allowing for precise attacks on the tumor. Moreover, the delivery method via ICT and/or ICV catheter ensures that these specially designed T cells reach the brain directly, potentially leading to more effective results with fewer side effects. Researchers are excited about this therapy because it represents a shift from traditional methods, harnessing the body's own immune system to combat cancer cells in a targeted and potentially more effective way.
What evidence suggests that this treatment might be an effective treatment for brain cancer?
Studies have shown that CAR T cell therapy, which targets specific proteins called EGFR and IL13Rα2, holds promise for treating brain cancer, such as high-grade gliomas. Previous research found that delivering CAR T cells directly to the brain was feasible and helped shrink tumors. In this trial, participants will receive EGFR/IL13Rα2 pool-CAR T cells, which target two proteins simultaneously and have proven more effective than those targeting just one. Although the improvement in survival rates remains limited, early studies suggest this therapy might offer advantages over standard treatments. This CAR T cell therapy aims to enhance the immune system's ability to attack cancer cells in the brain more effectively.12367
Who Is on the Research Team?
Behnam Badie
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with aggressive brain tumors like glioblastoma or high-grade astrocytoma that have come back or worsened after standard treatment. Participants must be in fair physical condition, have certain tumor markers (EGFR and IL13Rα2), and a life expectancy of at least 4 weeks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo leukapheresis, surgical resection, biopsy, and catheter placement followed by EGFR/IL13Rα2 pool-CAR T cell infusion every 7 days for up to 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at day 30, months 3, 6, 9, and 12, and then yearly for up to 15 years
Extension
Participants may receive additional cycles of EGFR/IL13Rα2 pool-CAR T cells per principal investigator and patient discretion
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells
- Intracranial Catheter Placement
Trial Overview
The study tests a new CAR T cell therapy made from the patient's own immune cells, engineered to target specific proteins on their brain tumor. The modified cells are delivered directly into the brain through a catheter to find the safest dose and observe side effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo leukapheresis followed by surgical resection, biopsy, and ICT and/or ICV catheter placement 1-3 weeks prior to cycle 1, day 0. Patients then receive EGFR/IL13Rα2 pool-CAR T cells via ICT and/or ICV catheter over 5 minutes on day 1 of each cycle. Cycles repeat every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of EGFR/IL13Rα2 pool-CAR T cells per PI and patient discretion and/or undergo additional leukapheresis as needed on study. Patients also undergo ECHO during screening, as well as FDG-PET, MRI, and blood, TCF, and CSF sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Intracerebroventricular bivalent CAR T cells targeting EGFR ...
Intrathecal bivalent CAR T cells targeting EGFR and IL13Rα2 in recurrent glioblastoma: phase 1 trial interim results. Nat Med 30, 1320–1329 (2024). [DOI] ...
CAR-T cell therapies are coming after glioblastoma
Recent clinical evidence suggests that the intracranial delivery of CAR-T cells is feasible and shows signs of antitumor activity. In the phase ...
Study Details | NCT07544992 | Locoregional ...
This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a ...
CAR-T cell therapy for the treatment of adult high-grade ...
Tandem CARs targeting IL-13Rα2 and HER2 or EGFRvIII have demonstrated superior anti-tumor responses and reduced antigen escape compared to ...
Effectiveness of CAR T-cell Therapy in Improving Overall ...
CAR T-cell therapy demonstrates limited but promising improvements over conventional treatments in overall survival in phase I studies.
Clinical Trials Using Autologous Anti-EGFR/ ...
Review the clinical trials studying autologous anti-egfr/anti-il13ralpha2 car t-cells on this list and use the filters to refine the results by age and ...
Intrathecal CRISPR-edited allogeneic IL-13Rα2 CAR T ...
Patients with recurrent high-grade glioblastoma have a median survival of 6-8 months, with limited therapeutic options.
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