E-SYNC T Cells for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test the safety of a new treatment using E-SYNC T cells, which modifies a person's immune cells to target and fight glioblastoma, a type of brain cancer. Participants will first receive chemotherapy to enhance the effectiveness of the E-SYNC T cells. The trial includes different groups to assess how varying doses affect safety and effectiveness. It is suitable for individuals with glioblastoma who have a specific marker on their cancer cells and have completed standard radiation therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you must be off systemic steroids for at least 3 days before certain procedures. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that E-SYNC T cells, a type of CAR T-cell therapy, are under investigation for treating glioblastoma, a type of brain cancer. Early results indicate that researchers are testing these cells for safety and identifying any side effects. In past studies, CAR T-cell therapies have demonstrated the ability to specifically target cancer cells.
This trial marks the first time E-SYNC T cells are tested in humans, so detailed safety information is still being collected. However, similar CAR T-cell therapies have shown that while side effects can occur, they are often manageable with medical care.
As this is an early-stage trial, the main goal is to assess the treatment's safety and patient tolerance. Researchers will closely monitor participants to ensure any side effects are quickly managed.12345Why do researchers think this study treatment might be promising for glioblastoma?
Unlike the standard treatments for glioblastoma, which typically involve surgery, radiation, and chemotherapy, E-SYNC T Cells offer a groundbreaking approach. These cells are engineered to specifically target the EGFRvIII mutation found in some glioblastoma tumors. This targeted mechanism could potentially increase the effectiveness of treatment by selectively attacking cancer cells while sparing healthy ones. Researchers are also excited because this method uses the body's own immune system, potentially leading to more durable and less toxic outcomes.
What evidence suggests that E-SYNC T Cells might be an effective treatment for glioblastoma?
Research shows that CAR T-cell therapy, such as E-SYNC T cells, holds promise for treating glioblastoma by directly targeting cancer cells. In this trial, participants will receive E-SYNC T cells, which are specially modified to find and attack the EGFRvIII protein, often present on glioblastoma cells. Studies have shown that targeting specific proteins on cancer cells can help shrink tumors and slow their growth. E-SYNC T cells aim to provide similar benefits by targeting this unique protein, potentially improving outcomes for patients with this difficult-to-treat cancer. Early results from similar CAR T-cell therapies suggest effectiveness, but further research is needed to confirm these findings.12567
Who Is on the Research Team?
Jennifer Clarke, MD, MPH
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Adults with a specific mutation in their epidermal growth factor receptor (EGFRvIII) who have been diagnosed with glioblastoma, a type of brain cancer. Participants must meet certain health standards and not be receiving other treatments that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants complete non-interventional, standard of care radiation therapy
Leukapheresis and Manufacturing
Participants undergo leukapheresis for the creation of E-SYNC T cells
Lymphodepleting Chemotherapy
Participants receive cyclophosphamide and fludarabine IV on days -5, -4, and -3
Treatment
Participants receive a single infusion of E-SYNC T cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- E-SYNC T Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hideho Okada, MD, PhD
Lead Sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
National Cancer Institute (NCI)
Collaborator