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Glioma - Healing Genes
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Glioma

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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


Phase 1

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility of the patient to participate
  2. 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
  3. A catheter into the tumor will be required where the investigatory treatment is infused over 5 to 10 minutes weekly for 3 weeks
  4. Optional additional treatments may continue while the patient’s modified cells are available, and if they are still eligible.
  5. 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

 

SPONSOR INFORMATION:

City of Hope Medical Center

National Cancer Institute (NCI)

Gateway for Cancer Research

Mustang Bio, Inc.

California Institute for Regenerative Medicine (CIRM)

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02208362

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