Phase I Study of CB-NK-TGF-ßR2-/NR3C1- in Recurrent Glioblastoma
This Phase I study is investigating a new treatment called CB-NK-TGF-betaR2-/NR3C1- for patients aged 12 and older with recurrent glioblastoma or gliosarcoma (brain tumors that have come back). This treatment uses specially engineered natural killer (NK) cells, which are immune cells, derived from cord blood. These cells are designed to help control the disease. Researchers want to find the safest and most effective dose of CB-NK-TGF-betaR2-/NR3C1-, which will be given directly into the tumor. They will also look at how well these NK cells work against the tumor and how they affect the immune system. The study plans to enroll 25 participants, but its current status is unclear.
- Study design
- This is a Phase I interventional study aiming to determine the best dose and safety of the treatment. It plans to enroll 25 participants.
- What's involved
- Participants will receive CB-NK-TGF-betaR2-/NR3C1- injected into their tumor and may undergo surgical resection (removal of the tumor).
- Compensation
- Not stated in the trial record.
- Follow-up
- The incidence of dose-limiting toxicities (DLTs) will be measured for up to 28 days.
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Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shiao-Pei S Weathers, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Incidence of dose-limiting toxicities (DLTs) (Group 1)Up to 28 days
Will determine maximum tolerated dose and safety of escalating doses of cord blood (CB)-(NK) cells patients with recurrent glioblastoma. A DLT is defined as any grade \>= 3 adverse event assessed as related to CB-NK cells by the investigator (that is, grade \>= 3 adverse drug reaction; grading according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03.