drugset / Trial / NCT05052957
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
NaSingle-groupOpen-labelTreatment
Summary
This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.
Timeline
- Start
- 2023-01-20
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | O6-benzylguanine | Small molecule | — | — |
| Subject | P140K-MGMT | Cell therapy | — | — |
| Subject | Temozolomide | Small molecule | — | — |
| Subject | carmustine | Small molecule | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |