drugset / Trial / NCT04196413
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
Phase 1
Recruiting
97 enrolled
Stanford University
Alex's Lemonade Stand Foundation · collabCalifornia Institute for Regenerative Medicine (CIRM) · collabCureSearch · collabNational Cancer Institute (NCI) · collabParker Institute for Cancer Immunotherapy · collab
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2020-06-04
- Primary completion
- 2028-07-31
- Completion
- 2043-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GD2 CAR T cells | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | GD2 CAR T cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | GD2 CAR T cells | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | GD2 CAR T cells | Cell therapy | 1e+07 cells | Intravenous |
| Subject | GD2 CAR T cells | Cell therapy | 3e+07 cells | Intravenous |
| Subject | GD2 CAR T cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | GD2 CAR T cells | Cell therapy | 1e+08 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 750 mg/m2 | Intravenous |