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 called CAR T-cell therapy for individuals with aggressive brain cancer, specifically grade III or IV gliomas that have recurred after initial improvement. The treatment modifies a person’s immune cells in a lab to better target cancer cells, focusing on a protein called GARP. Participants receive these modified T-cells through an infusion to evaluate the therapy's safety and effectiveness. Candidates include those with a history of high-grade gliomas, confirmed recurrent disease, and who have not taken certain medications like bevacizumab. 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 new therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anti-cancer agents, like chemotherapy, 14 days before starting the study and remain off them during the trial. If you're on steroids, you must be on a low dose (4mg or less per day) and not increasing the dosage. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that anti-GARP CAR T cell therapy is likely to be safe for humans?
Research shows that anti-GARP CAR T-cell therapy might be safe and manageable. Studies have found that CAR T-cell therapy is generally safe for patients with glioblastoma, a type of brain cancer. While the treatment appears safe, its effectiveness can vary. Researchers have safely administered CAR T cells in different ways, including directly to the tumor area. However, the treatment's ability to shrink tumors or slow cancer growth can differ for each person. As this trial is in its early stages, safety remains a primary focus, and researchers will closely monitor any side effects. Prospective participants should consult their doctor to understand the possible risks and benefits.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain cancer, which often involve surgery, radiation, and chemotherapy, anti-GARP CAR T cell therapy offers a novel approach by utilizing a patient's own immune system to fight the cancer. This treatment is unique because it involves engineering T cells to target GARP, a specific protein associated with cancer cells, potentially providing a more precise attack on the tumor. Additionally, the delivery method is innovative, as the modified T cells are infused directly into the brain's cavity, which could enhance their effectiveness and minimize systemic side effects. Researchers are excited about this approach due to its potential to offer a more targeted and less toxic treatment option for brain cancer patients.
What evidence suggests that this treatment might be an effective treatment for brain cancer?
Research suggests that anti-GARP CAR T-cell therapy, which participants in this trial will receive, could help treat recurring severe brain tumors, known as grade III or IV gliomas. This therapy modifies a patient's own immune cells, called T cells, to attack cancer cells. Studies have found that targeting a protein called GARP, present in certain brain tumor cells, can improve treatment outcomes. In animal studies, this therapy successfully treated glioblastoma, a type of brain cancer. Although human studies remain limited, early results show promise for this therapy's ability to combat aggressive brain tumors.13456
Who Is on the Research Team?
James B Elder, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with grade III or IV gliomas, a type of brain tumor, that have returned after initial treatment. Participants must be in good physical condition with adequate organ function and no serious medical issues that would prevent them from undergoing the procedures involved in the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and Surgery
Patients undergo apheresis and surgery for CSF reservoir placement
Treatment
Patients receive anti-GARP CAR T intracavitary infusion on days 14, 21, 28, 35, and 42
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Annual follow-up for at least 15 years to monitor overall survival and long-term effects
What Are the Treatments Tested in This Trial?
Interventions
- Anti-GARP Chimeric Antigen Receptor-T Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor