GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-60
SponsorStanford University

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

97 Participants
are divided into 4 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