RecruitingPhase 1NCT06186401

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells

Phase 1 Study of Autologous Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13R alpha2 CAR (E-SYNC) T Cells in Adult Participants With EGFRvIII+ Glioblastoma

Sponsor

Hideho Okada, MD, PhD

Enrollment

20 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

Glioblastoma EGFR Gene Mutation MGMT-Unmethylated Glioblastoma Recurrent Glioblastoma

Summary

This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so the CAR T cells will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine before treatment with CAR T cells may make the CAR T cells more effective.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a sophisticated CAR-T cell therapy called E-SYNC for people with a type of brain cancer called glioblastoma. These specially engineered immune cells are designed to detect and attack brain tumor cells using two different targets, potentially overcoming the way glioblastoma evades the immune system. **You may be eligible if...** - You are 18 or older - You have been diagnosed with glioblastoma or another brain cancer that has the right target proteins - You have a Karnofsky performance score of 70 or higher (able to care for yourself with some assistance) - Your blood counts and organ function meet required levels - You have not responded to standard treatments **You may NOT be eligible if...** - You have active severe infections - You have autoimmune disease requiring systemic treatment - Your blood counts or organ function are too low - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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