Genetically Modified T-cell Therapy for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for brain cancer, specifically malignant glioma that hasn't responded to standard treatments or has recurred. The trial aims to determine if genetically modified T-cells can fight the cancer by recognizing and attacking tumor cells. Participants will receive IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes. These T-cells are taken from participants' blood, modified in a lab, and reintroduced to target the cancer. Individuals with grade III or IV glioma that has worsened despite standard treatments might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance 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, there are specific waiting periods after certain chemotherapy treatments before you can start the trial, such as 6 weeks for nitrosourea-containing regimens and 4 weeks for bevacizumab.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that IL13Ralpha2-specific CAR T cells are generally safe. In one study, this treatment produced promising results for some patients, with manageable side effects. Another study found that these CAR T cells effectively targeted and destroyed brain tumor cells.
The IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR T cells share a similar safety profile. Studies indicate that they are designed to enhance the immune system's response to cancer cells. This optimization aims to improve both safety and effectiveness.
Although these treatments are still in early testing stages, they are intended to be safe. However, since they are in the early phases, it is important to note that information on long-term safety is still being collected.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they represent a novel approach to tackling brain cancer by modifying a patient's own immune cells to better target cancer cells. Unlike the standard treatments like surgery, chemotherapy, or radiation, which broadly attack cancer, these therapies use genetically engineered T-cells to specifically target the IL13Ralpha2 protein, which is often found on brain cancer cells but not on healthy cells. Additionally, these treatments offer innovative delivery methods, such as intratumoral and intraventricular administration, allowing for the precise delivery of these potent cells directly to the cancer site, potentially increasing effectiveness and reducing side effects. By enhancing the body's natural immune response, these CAR T-cell therapies could offer new hope for patients with brain cancer.
What evidence suggests that this trial's treatments could be effective for brain cancer?
Research has shown that specially modified T-cells targeting a protein called IL13Ralpha2 could help treat brain cancer. These T-cells are engineered to find and destroy glioma cells, a type of brain tumor cell. In this trial, participants will receive Tcm-derived CAR T cells through various delivery methods, including intratumoral, intracavitary, and intraventricular approaches, as well as dual delivery methods. Earlier studies found these modified T-cells effective in attacking and eliminating tumor cells in patients with recurring high-grade glioma. Adding a component called the 4-1BB co-stimulatory domain boosts the T-cells' ability to fight cancer. While the initial results are promising, more research is needed to fully understand their potential in treating brain cancer.12346
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 patients with malignant glioma that has returned or hasn't responded to treatment. They must have had progression after initial radiation, be able to consent, not need excessive steroids during therapy, and meet specific blood and organ function criteria. Pregnant women can't participate, nor those needing dialysis, with other active cancers, severe infections or major surgery recovery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive genetically modified T-cell immunotherapy in a dose-escalation study with initial low dose followed by higher doses in subsequent cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 4 weeks, 3, 6, 8, 10, and 12 months, and then yearly for 15 years.
What Are the Treatments Tested in This Trial?
Interventions
- IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes
- IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes is already approved in United States for the following indications:
- Recurrent or refractory IL13Rα2-positive brain tumors in children
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Food and Drug Administration (FDA)
Collaborator