The primary purpose of this study is to test whether GD2-CAR T cells can be successfully made
from immune cells collected from children and young adults with H3K27M-mutant diffuse
intrinsic pontine glioma (DIPG) or spinal H3K27M-mutant diffuse midline glioma (DMG).
H3K27Mmutant testing will occur as part of standard of care prior to enrollment.
Determine the feasibility of manufacturing autologous T cells transduced with
14g2a-CD8-BBz-iCasp9 retroviral vector expressing GD2 Chimeric Antigen Receptor
(GD2CART) for administration in subjects with H3K27M+ diffuse intrinsic pontine glioma
(DIPG) or subjects with spinal H3 K27M-mutant diffuse midline glioma (DMG) using a
retroviral vector and dasatinib in the Miltenyi CliniMACS Prodigy system.
Assess the safety and identify the maximum tolerated dose (MTD) and/or recommended phase
2 dose (RP2D) of GD2CART in subjects with H3K27M+ DIPG administered after
cyclophosphamide/fludarabine-based lymphodepletion regimen using the following dose
escalation schedule: DL1: 1e6 transduced T cells/kg; DL2: 3e6 transduced T cells/kg;
DL3: 10e6 transduced T cells/kg.
Assess the safety of the MTD/RP2D of GD2CART in subjects with spinal H3K27M mutant DMG.
In a preliminary manner, assess clinical benefit of GD2CART at the RP2D in subjects with
H3K27M DIPG or spinal H3 K27M-mutant DMG.
If unacceptable toxicity occurs that is possibly, probably or likely related to GD2CART,
assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the
genetically engineered cells and resolve toxicity.
Glioma of Brainstem,
Glioma of Spinal Cord,
spinal cord glioma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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