A Phase1 Clinical Trial Evaluating Locoregional Delivery Of Engineered NK Cells Containing IL13Ra And EGFvIII Chimeric Antigen Receptor (CAR), IL-21 Secretion And Deleted TGF-BetaR2 And NR3C1 In Recurrent Glioblastoma
M.D. Anderson Cancer Center
Summary
To find the best method of administering NK cells in patients with recurrent glioblastoma.
Description
Primary Objectives 1. To undertake a window of opportunity (WOO) clinical trial to compare the biological endpoints of Dual CAR Dual KO NK cells persistence, immunological phenotype and anti-tumor function after administration of Dual CAR Dual KO NK cells via 3 different routes: intra-tumoral, intra-ventricular or intra-arterial injection. By quantitatively assessing post-treatment specimens, the trial will determine the optimal route of administration of this agent. 2. To assess the safety of Dual CAR Dual KO NK cells after administration via 3 different routes: intra-tumoral, intra-ventricu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria 1. Male or female subjects aged ≥ 18 years. 2. Histologically confirmed supratentorial 2021 World Health Organization recurrent glioblastoma (IDH-wildtype GBM), gliosarcoma, or recurrent IDH-mutant WHO grade 4 astrocytoma, with any prior number of recurrences. 3. Have received prior radiation and temozolomide therapy. 4. Single tumor no larger than 5 cm in its greatest diameter. 5. Karnofsky Performance Status (KPS) score of \>70. 6. Has a baseline brain MRI obtained no more than 30 days prior to NK cell infusion 7. Adequate hematological function defined by white blood c…
Interventions
- DrugNK Cells
Given by Ommaya Reservoir
- DrugNK Cells
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas