CAR T-Cell Therapy for Brain Cancer
(iCAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for brain cancer using altered T cells, a type of immune cell, combined with antibodies to target and destroy cancer cells. The focus is on HER2-positive brain tumors, where tumor cells have a specific protein on their surface that the treatment can target. Researchers aim to find the safest dose of these modified cells and monitor for any side effects. People with HER2-positive brain cancer that hasn't responded to other treatments might be suitable for this study. As a Phase 1 trial, this research seeks to understand 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 requires that you stop other investigational cancer treatments two weeks before the CAR T cell infusion, but you can continue taking Temozolomide up to 48 hours before the infusion. Dexamethasone is allowed up to a total dose of 2 mg per day if needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that HER2-CAR T cells effectively fight cancer cells in lab tests and animal studies. In earlier research, these specially modified cells successfully targeted and attacked tumors. Reports indicate that HER2-CAR T cells can be safely administered to patients in various ways, although results may vary.
While the FDA has not yet approved HER2-CAR T cells, clinical trials have tested them for safety. The research aims to find the highest dose patients can tolerate without serious side effects. Previous experiences with CAR T cells have demonstrated that they can cause side effects, but these are often manageable. The current study seeks to understand these effects better and find ways to reduce them.12345Why are researchers excited about this study treatment for brain cancer?
Most treatments for brain cancer, like surgery, radiation, and chemotherapy, work by directly attacking the cancer cells or shrinking tumors. However, HER2-specific CAR T-cell therapy works differently by harnessing the body's immune system. This treatment involves modifying a patient's own T-cells to specifically target and attack cancer cells expressing the HER2 protein, which is often overexpressed in certain brain cancers. Researchers are excited because this targeted approach could offer a more precise attack on cancer cells while sparing healthy ones, potentially leading to fewer side effects and more effective outcomes.
What evidence suggests that HER2-specific T cells might be an effective treatment for brain cancer?
Research has shown that a new treatment using specially modified immune cells, called HER2-specific CAR T-cells, can effectively fight tumors in both lab tests and live studies. These modified cells are designed to find and destroy tumor cells with a marker called HER2, often found on brain tumors. In some studies, MRI scans revealed that brain tumors shrank significantly after treatment with these HER2-CAR T-cells. In this trial, participants will be assigned to either a High Risk or Standard Risk arm, where researchers will evaluate different dosing schedules of HER2-specific T cells. Although the results are promising, the treatment does not work as well on solid tumors like brain cancer as it does on blood cancers. This treatment remains experimental, and further research is needed to confirm its efficacy and safety.12467
Who Is on the Research Team?
Meenakshi Hegde, MD
Principal Investigator
Baylor College of Medicine - Texas Children's Hospital
Nabil M Ahmed, MD
Principal Investigator
Baylor College of Medicine - Texas Children's Hospital
Shoba Navai, MD
Principal Investigator
Baylor College of Medicine - Texas Children's Hospital
Are You a Good Fit for This Trial?
This trial is for patients with brain cancer that tests positive for a protein called HER2. Participants should have recurrent or resistant tumors, be able to undergo surgery if needed, and have a moderate ability to perform daily activities (Karnofsky/Lansky score ≥60). They must understand and sign the consent form.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three injections of HER2-CAR T cells two weeks apart, with dose escalation based on safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood tests and imaging studies
Long-term Follow-up
Participants are monitored for long-term side effects of gene transfer up to 15 years
What Are the Treatments Tested in This Trial?
Interventions
- HER2-specific T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
The Methodist Hospital Research Institute
Collaborator
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator