drugset / Trial / NCT05052957

hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)

NCT05052957

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

EvaluationDrugModalityDoseRoute
Subject O6-benzylguanine Small molecule
Subject P140K-MGMT Cell therapy
Subject Temozolomide Small molecule
Subject carmustine Small molecule
Background filgrastim Protein / enzyme biologic