Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2
I. To assess the safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy in
research participants with recurrent or refractory/ progressive malignant glioma (WHO Grades
3 or 4).
II. To assess the safety of convection enhanced delivery (CED) of recombinant human
Interleukin-2 (rhuIL-2) used in conjunction with GRm13Z40-2 CTL adoptive transfer.
I. To investigate the ability of 9-(4-fluoro-3-hydroxy-methyl-butyl) guanine (18FHBG)
positron emission tomography PET to image GRm13Z40-2 CTL's in research participants.
II. To study the impact of concurrent dexamethasone administration on the tempo and
magnitude of T cell allograft rejection responses in treated research participants by
tracking the frequency of anti-GRm13Z40-2 immune responses in serially acquired peripheral
III. To evaluate ganciclovir administration for ablating transferred GRm13Z40-2 in vivo
should significant graft-mediated toxicities be encountered.
OUTLINE: Patients receive GRm13Z40-2 therapeutic allogeneic lymphocytes intratumorally (IT)
over 10 minutes on days 1 and 3 and aldesleukin IT over 3 hours on days 2-5 (days 1-5 in
week 2). Treatment repeats every week for 2 courses in the absence of disease progression or
After completion of study treatment, patients are followed annually for at least 15 years.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy
Daily for first 2 weeks, weekly for month 1, every other week for month 2 , monthly for 6 months
Beckman Research Institute
United States: Food and Drug Administration
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