Genetically Modified T-cell Therapy for Brain Cancer
Trial Summary
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.
What data supports the effectiveness of the treatment Genetically Modified T-cell Therapy for Brain Cancer?
Research shows that IL13Rα2-specific CAR T cells, which are part of this treatment, have demonstrated significant anti-tumor activity and improved survival in animal models of glioblastoma (a type of brain cancer). These T cells specifically target the IL13Rα2 protein found on tumor cells, leading to effective tumor cell killing without affecting normal brain tissue.12345
What safety data exists for IL13Ralpha2-specific CAR T cell therapy in humans?
IL13Ralpha2-specific CAR T cell therapy has been studied for its safety, particularly focusing on its ability to target cancer cells without affecting normal tissues. Research indicates that certain designs of these CAR T cells can selectively target tumor cells with minimal off-target effects, which is important for safety. However, like other CAR T cell therapies, there is a potential risk of severe side effects such as cytokine release syndrome and neurotoxicity, which are influenced by the specific structural components of the CAR T cells.12346
What makes the IL13Ralpha2-specific CAR T cell treatment unique for brain cancer?
This treatment is unique because it uses genetically modified T cells that specifically target the IL13Ralpha2 protein, which is commonly found in glioblastoma (a type of brain cancer) but not in normal brain tissue. The inclusion of the 4-1BB costimulatory domain enhances the selectivity and effectiveness of these T cells, making them more potent against tumors while reducing the risk of attacking healthy cells.13478
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.
Research Team
Behnam Badie
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
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
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.
Treatment Details
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