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NK Cells

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

  • RegistryNCT07579208
  • PhasePhase 1
  • StatusRecruiting
  • ConditionRecurrent Glioblastoma
  • SponsorM.D. Anderson Cancer Center
How NK Cells works1 min

The drug

What is being tested.

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-ventricular or intra-arterial injection. Secondary Objectives 1. To determine response as measured by Response Assessment in Neuro-Oncology (RANO), progression free survival (PFS), time to progression (TTP), and overall survival (OS). 2.

The study

How the trial runs.

To find the best method of administering NK cells in patients with recurrent glioblastoma.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Eligibility Criteria
  • Male or female subjects aged ≥ 18 years.
  • 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.
  • Have received prior radiation and temozolomide therapy.
  • Single tumor no larger than 5 cm in its greatest diameter.
  • Karnofsky Performance Status (KPS) score of \>70.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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