Brain cancer experts at City of Hope, a world-renowned independent cancer and diabetes research and treatment center are conducting a Phase 1 (first in man) research study (clinical trial) to evaluate the safety and feasibility of the investigational product MB-101 (also known as IL13Rα2-specific CAR-T cells) in adult patients with brain tumors that have spread to the spinal fluid and surrounding brain tissue. This condition is called Leptomeningeal Disease (pronounced as Lepto-men-en-geal) and is a consequence of primary brain tumors such as glioblastoma, ependymoma or medulloblastoma.
MB-101 is made from a specific type of cells from your body (called T-cells) that are collected at the hospital by a process called leukapheresis [your blood is passed through a machine that takes out the white blood cells (cells that help you fight infections and other diseases) and returns all other blood cells and plasma (the fluid blood cells are suspended in) back into the bloodstream]. Your white blood cells are then modified in a laboratory so that they can possibly kill cancer cells. These cells are called chimeric antigen receptor T-cells, or CAR-T cells. CAR-T cell therapy is an “immune treatment,” because it works with immune cells in your body to possibly find and kill cancer cells.
MB-101 (IL13Rα2-specific CAR T cells) is an investigational product. An investigational product is one that has not been proven to be safe and effective and is not approved by the US Food and Drug Administration (FDA) or any other government agency. An investigational product can be administered only in a research study after it has been approved for such use by the FDA.
For complete information about the MB-101 Phase 1 study eligibility requirements please visit the United States Government Clinical Study Registry.
The study is currently recruiting participants at City of Hope in Durante, CA near Los Angeles. Patients must be willing and able to travel to the study site to be evaluated and, if enrolled, to be treated for the duration of the study and for any additional follow up visits.
Participating in a clinical study is an important voluntary decision. If you believe this clinical trial might be a good fit and you are interested in participating, please take the next step to see if you are eligible to participate.
Anyone participating in a clinical study should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical study, please talk to your physician first.
Before you consider enrolling in any clinical study make sure you get as much information as you can about the study, study site(s), investigators and potential risks and benefits of participation.
For more information about the MB-101 Phase 1 clinical study, eligibility requirements and study site information, please visit the United States Government Clinical Study Registry.
For more information about the MB-101 trial, please visit the City of Hope’s CAR-T clinical trials page or contact the principal investigator Dr. Lisa Feldman at firstname.lastname@example.org. Patients may also call City of Hope’s Neurosurgery department at (626)218-9393.