About this trial
The primary purpose of this study is to test whether CAR T cells targeting GD2 (GD2CART) can be successfully made and safely given to children and adults with H3K27M-mutant diffuse midline glioma (DMG). Eligible subjects may have DMG arising in the pons (called difuse intrinisic pontine glioma, DIPG), the spinal cord, or other areas of the brain such as a thalamus
Eligibility criteria
Qualifiers
Disease Status: Diagnosis of H3K27M mutant diffuse midline glioma (DMG)
H3K27M or H3K27I mutation. Confirmed by CLIA test.
Age: Greater than or equal to 2 year of age and less than or equal to 60 years of age.
At least 4 weeks following completion of standard upfront radiation therapy.
Disqualifiers
For Dose Escalation: Bulky tumor involvement of cerebellar vermis or hemispheres (pontocerebellar peduncles involvement is acceptable), or thalamic lesions that in the investigator's assessment place the subject at unacceptable risk for herniation.
Clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction, as determined by the clinical investigator; or primary cervical cord tumors above C6/7 that represent a high risk of respiratory compromise, as determined by the clinical investigator.
Current systemic corticosteroid therapy above physiologic replacement levels.
Ongoing use of dietary supplements, alternative therapies or extreme diet modifications or any medication not approved by the investigators
Trial design
Treatments tested in this trial
- GD2 CAR T cells
- Fludarabine
- Cyclophosphamide
- Rituximab
Treatment groups
Sponsors and collaborators
Stanford University
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
CureSearch
Collaborator
National Cancer Institute (NCI)
Collaborator
Alex's Lemonade Stand Foundation
Collaborator
Parker Institute for Cancer Immunotherapy
Collaborator