About this trial
To find the best method of administering NK cells in patients with recurrent glioblastoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks since last dose of agent administration.
Has known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v5.0), any history of anaphylaxis, within 5 months.
Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1/2 antibodies); HTLV1 and/or HTLV2; active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Participants with prior HBV vaccination (anti-HBs positive, HBsAg negative, anti-HBc negative) will NOT be excluded.
Trial design
Single group
Treatments tested in this trial
NK Cells
DrugGiven by Ommaya Reservoir
NK Cells
DrugGiven by IV
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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