A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)
M.D. Anderson Cancer Center
Summary
This phase I trial is to find out the best dose, possible benefits and/or side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \[CB\]-NK-TGF-betaR2-/NR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-/NR3C1- cells are genetically changed immune cells that may help to control the disease.
Description
PRIMARY OBJECTIVES: * To determine the safety and tolerability of intratumoral injection of escalating doses of allogeneic CB-NK-TGF-£\]R2-/NR3C1- in patients with recurrent grade 4 astrocytoma, * To determine the maximum tolerated dose (MTD) and the occurrence of dose limiting toxicities (DLTs) (Group 1) of CB-NK-TGF-£\]R2-/NR3C1- administered via IT injection in patients with recurrent grade 4 astrocytoma * To evaluate the immunological phenotype and anti-tumor function of NK cells in resected tumor tissue after treatment with CB-NK-TGF-âR2-/NR3C1- in the surgical expansion group (Group 2).…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Signed and dated informed consent. 2. Male or female participants aged ≥ 12 years on the day of signing informed consent. 3. Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent gliosarcoma with any prior number of recurrences, and who have received prior radiation and temozolomide therapy. Participants will be eligible if the original histology was lower-grade glioma grade 2 or 3 and a subsequent histological d…
Interventions
- BiologicalCord Blood-derived Expanded Allogeneic Natural Killer Cells
Given CB-NK-TGF-betaR2-/NR3C1- intratumorally
- ProcedureResection
Undergo surgical resection
Location
- M D Anderson Cancer CenterHouston, Texas