Journal
ONCOTARGET
Volume 8, Issue 51, Pages 89256-89268Publisher
IMPACT JOURNALS LLC
DOI: 10.18632/oncotarget.19204
Keywords
NK cell; NK-92; clinical trial; lymphoma; multiple myeloma
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Funding
- Ontario Institute for Cancer Research
- Princess Margaret Hospital Foundation
- Toronto General & Western Hospital Foundation
- Gloria and Seymour Epstein Chair in Cell Therapy and Transplantation of the University of Toronto
- Gloria and Seymour Epstein Chair in Cell Therapy and Transplantation of the University Health Network
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Background: Autologous NK cell therapy can treat a variety of malignancies, but is limited by patient-specific variations in potency and cell number expansion. In contrast, allogeneic NK cell lines can overcome many of these limitations. Cells from the permanent NK-92 line are constitutively activated, lack inhibitory receptors and appear to be safe based on two prior phase I trials. Materials and Methods: We conducted a single-center, non-randomized, non-blinded, open-label, Phase I dose-escalation trial of irradiated NK-92 cells in adults with refractory hematological malignancies who relapsed after autologous hematopoietic cell transplantation (AHCT). The objectives were to determine safety, feasibility and evidence of activity. Patients were treated at one of three dose levels (1 x 10(9) cells/m(2), 3 x 10(9) cells/m(2) and 5 x 10(9) cells/m(2)), given on day 1, 3 and 5 for a planned total of six monthly cycles. Results: Twelve patients with lymphoma or multiple myeloma who relapsed after AHCT for relapsed/refractory disease were enrolled in this trial. The treatment was well tolerated, with minor toxicities restricted to acute infusional events, including fever, chills, nausea and fatigue. Two patients achieved a complete response (Hodgkin lymphoma and multiple myeloma), two patients had minor responses and one had clinical improvement on the trial. Conclusions: Irradiated NK-92 cells can be administered at very high doses with minimal toxicity in patients with refractory blood cancers, who had relapsed after AHCT. We conclude that high dose NK-92 therapy is safe, shows some evidence of efficacy in patients with refractory blood cancers and warrants further clinical investigation.
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