Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients With Recurrent/Refractory Malignant Glioma
Doctors at the City of Hope Medical Center in California are recruiting participants for a large study on how well a gene-modified immunotherapy can treat malignant glioma, glioblastoma, or other recurrent brain neoplasm. The investigational therapy will withdraw immune T-cells from the patient and, utilizing gene editing, the white blood cells will be trained to target their tumors. Then the modified T-cells will be infused directly to the patient’s tumor weekly for 3 weeks. As long as the patient is still eligible and opts in, more treatments may continue, and may be into the tumor directly, intracranially or via peripheral IV (in the arm).
Follow-up to track the progress of the tumors through lab assessments, MRI, and physical assessments will be required for up to 6 weeks, and further follow up will be required for up to 15 years.
- Be 12 to 75 years of age
- Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG) after completing standard therapy.
- Life expectancy > 4 weeks
- Patient must meet eligibility screening for various lab criteria
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate
- White blood cells will be drawn and over several weeks, the patient will receive no treatment while the cells are gene-modified in a lab
- A catheter into the tumor will be required where the investigatory treatment is infused over 5 to 10 minutes weekly for 3 weeks
- Optional additional treatments may continue while the patient’s modified cells are available, and if they are still eligible.
- Follow up will be required for up to 6 weeks, and additional further follow up for up to 15 years/
LOCATIONS AND CONTACTS:
The study site is at the City of Hope Medical Center in Duarte, California. Map.
Primary contact: Paige Myers-McNamara | [email protected] | 626-218-9393
City of Hope Medical Center
National Cancer Institute (NCI)
Gateway for Cancer Research
Mustang Bio, Inc.
California Institute for Regenerative Medicine (CIRM)
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