At a glance
ClinicalIndex Comparison Record- ✓H3K27M or H3K27I mutation confirmed by CLIA test
- ✓Age 2 to 60 years
- ✓At least 4 weeks from completion of standard upfront radiation therapy
- ✓At least 3 weeks post chemotherapy or 5 half-lives (whichever shorter) since prior systemic therapy; 3 months for immune checkpoint therapy
- ✕Dose escalation: bulky cerebellar/thalamic lesions at unacceptable risk for herniation; Dose expansion: bulky disease at unacceptable herniation risk (thalamic DMG permitted)
- ✕Clinically significant swallowing dysfunction or primary cervical cord tumors above C6/7 with high respiratory compromise risk
- ✕Current systemic corticosteroid therapy above physiologic replacement levels
- ✕Ongoing dietary supplements, alternative therapies, extreme diet modifications, or non-approved medications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2CART) for H3K27M-mutant Diffuse Midline Glioma (DMG)
In Brief
A Phase 1 clinical trial evaluating GD2 CAR T cells, Fludarabine, and 2 other interventions for Glioma of Spinal Cord and Glioma of Brainstem. Currently recruiting, targeting 97 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
Autologous T-Cells transduced with retroviral vector (14g2a-CD8.BB.z.iCasp9) expressing GD2-chimeric antigen receptor
Fludarabine 30 mg/m2 per day IV for days -4, -3, -2
Cyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2
First round: 750 mg/m2 per day IV for days -6 and -5. Subsequent rounds: 750 mg/m2 per day IV for day -5.