Engineered T Cell Therapy for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the safest dose and possible side effects of a new T cell therapy for brain cancer patients with glioma that has either returned or isn't responding to treatment. The therapy uses engineered T cells, which are immune cells modified to target and potentially kill cancer cells. Participants with a grade III or IV glioma, or a grade II glioma that has progressed and has specific tumor characteristics, may qualify for this study.
As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.
Do I need to stop my current medications for the trial?
The trial requires a 'washout' period (time without taking certain medications) for some treatments. You must stop nitrosourea-containing chemotherapy for at least 6 weeks, Temodar for 23 days, and other non-nitrosourea chemotherapy for 4 weeks before starting the trial. If you are on a targeted agent, a 2-week waiting period is needed, except for bevacizumab, which requires a 4-week washout.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that HER2-targeting CAR-T cells, similar to the HER2(EQ)BBζ/CD19t+ T cells used in this trial, have been effective against tumors in past studies. Patients generally tolerated these cells well, although some experienced mild side effects like headaches or tiredness, which are common with such treatments.
For HER2(EQ)BBζ/CD19t+ Tn/mem cells, research is closely examining their safety and effectiveness. In earlier studies with similar treatments, these cells were administered safely, and side effects were usually mild and manageable.
Since this trial is in an early stage, it primarily focuses on identifying the safest dose and understanding any side effects. The treatment is still being tested for safety, and any serious risks are not fully known yet. However, other studies suggest that these T cells are generally well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment for brain cancer because it uses engineered T cells, specifically HER2(EQ)BBζ/CD19t+ T cells, which offer a fresh approach compared to traditional therapies like chemotherapy and radiation. Unlike standard treatments, these T cells are delivered directly into the tumor or brain cavities, potentially increasing their effectiveness by targeting cancer cells more precisely. Additionally, the ability to continue infusions based on patient response allows for a more personalized treatment strategy, which could lead to better outcomes and fewer side effects. This innovative method of using the body’s own immune cells to fight cancer is a promising advancement that sets it apart from current therapies.
What evidence suggests that this trial's treatments could be effective for brain cancer?
Research has shown that CAR-T cells targeting HER2 proteins effectively combat tumors in both lab tests and living organisms. These cells are designed to attack specific proteins on cancer cells, aiding in their destruction. In this trial, participants may receive HER2(EQ)BBζ/CD19t+ Tcm cells, known for their ability to target and kill glioma cells, a type of brain cancer. Another trial arm involves HER2(EQ)BBζ/CD19t+ Tn/mem cells, which are part of ongoing research into new cancer treatments. These cells show promise by harnessing the body's immune system to fight tumors. Although evidence is still emerging, these treatments offer hope for addressing hard-to-treat brain cancers.23678
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 with recurrent or treatment-resistant Grade III-IV glioma. They must have good venous access, understand and consent to the study, not suffer from severe heart issues or uncontrolled seizures, and have certain blood levels within normal ranges. Participants need a confirmed diagnosis of HER2+ glioma, be able to tolerate minimal steroids during therapy, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive autologous HER2(EQ)BBzeta/CD19t+ T cells via catheter over 5 minutes weekly for 3 weeks. Additional infusions may be given based on eligibility and product availability.
Optional Infusions
Participants may receive additional T cell infusions based on clinical response and eligibility.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- HER2(EQ)BBζ/CD19t+ T cells
- Leukapheresis
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator