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Phase II Trial of BG and TMZ with P140K MGMT+ Hematopoietic Progenitors in GBM
NCT05052957Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2023
- Primary completion
- Nov 2026
- Countries
- 1
- Modality
- Gene Editing, Gene Silencing, Stem Cell Therapies
- Drugs
- LG631
- Conditions
- glioblastoma multiforme (GBM)Gliosarcoma (GS)
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Overview
Phase 2, open-label, single-arm trial of LG631 in glioblastoma multiforme (GBM) and Gliosarcoma (GS). Primary endpoints: Percent of participants able to complete treatment at 10 years, Incidence of adverse events and 1 more. Started Jan 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
stem cell mobilization after radiation therapy
Participants will receive stem cell mobilization after 6 weeks of standard of care radiotherapy, followed by SOC chemotherapy and P140K-MGMT infusion.
03
Who it enrols
Adults with newly diagnosed, resected supratentorial glioblastoma or gliosarcoma, unmethylated MGMT, no IDH1/2 mutations, adequate organ function, and candidates for autologous transplant.
04
Endpoints
Primary
Percent of participants able to complete treatment
Incidence of adverse events
Overall Survival
Secondary
Myelosuppression
Detection of P140K transduced BG and TMZ resistant cells
Enrichment of P140K-MGMT
Tumor Response using imaging
Progression-Free Survival using imaging
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