Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells

Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Week 1 and Monday of Week 2). Dose will be escalated in an inter-patient stepwise fashion consisting of 3 dose levels.

Trial Details

NCT ID
NCT04254419
Phase
PHASE1
Sponsor
Nationwide Children's Hospital
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • NK cells
Locations (sample)
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Diagnosis:
  • Recurrent, refractory, or progressive malignant CNS tumor
  • Patients with a histologically confirmed diagnosis of a CNS tumor that is recurrent, progressive, or refractory with the exception of diffuse midli…
  • Patients should be deemed candidate for placement of an Ommaya reservoir placed intra-cavitary/intra-tumoral or a programable VP shunt.

For full eligibility, visit ClinicalTrials.gov.

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