Title: Clinical data of phase I-II of allogeneic NK cell Therapy in 70 patients infected by COVID-19 in 4 hospitals of IRAN

Biography:

Dr. Sahar Shojaei is founder and CEO of Middle East Gene and Cell Therapy company (MEGCT) in IRAN. She has Ph.D. of molecular genetics. She works in cell therapy field of cancer and other immune related diseases and introduced some novel immune cell therapy clinical protocols in this field. NK cell therapy, Car T cell therapy and Dendritic cell therapy is developed by her and is ongoing in multicenter clinical trial for evaluation safety and efficacy of them for different blood and solid cancers.  

Abstract

Despite various vaccine developments and approaches that directly target the virus or block viral entry, finding an appropriate treatment in covid-19 infected patients has become a major focus. Natural killer (NK) cells are a pivotal component of the innate immune system that show anti-viral activities without dependency to specifically antigen recognition. This phase I/II study evaluated the safety and efficacy of allogeneic NK cell therapy in treatment of patients with SARS-CoV-2 pneumonia in 4 hospitals of IRAN. The main goals of our study were to evaluate the safety and efficacy of allogeneic NK cell therapy in patients with COVID-19 pneumonia and find an appropriate dose which provides a satisfied outcome in those patients.
Methodology and Theoretical Orientation: CD56 positive Nk cells were isolated from healthy donor Leukapheresis product using CliniMacs plus device. Nk cells were activated in cell culture medium NK GMP Medium (Milteny biotec) containing IL-2 and IL-15. The cells were characterized using flow cytometry analysis and K562 cytotoxicity assay, Then infused intravenously to COVID-19 patients After 14 days activation, cells infused to the patients that had inclusion criteria. Increasingly multiple doses of peripheral blood-derived NK cells (0.1-2 × 10⁷ cells/kg body weight) were infused to 5 patient groups (in each one 10 patients) with COVID-19 pneumonia (n=50) compared to 2 patients' placebo and control groups. The treatment outcomes were followed for 28 days for primary outcome and 1 year for secondary outcome.
Findings: There were no serious adverse events associated with NK cells infusion. Patients without underling diseases or experience of intubation or cytokine storm phenomenon showed 94.28% survival rate in comparison to the control and placebo groups and most patients. Moreover, the longevity of patients in the cohorts receiving 0.1, 0.5 and 1 × 10⁷ cells/kg was increased significantly when compared with the control and placebo groups.
Conclusion & Significance: These data indicate that allogeneic NK cells therapy was safe and tolerable for patients with COVID-19. Also, clinical data show the promising antiviral activities against Covid-19 virus. In a severe infection, Nk cells treatment demonstrates lower mortality rate, lower weight loss, lower lung viral load and reduced lung injury along with reduced inflammation. These results support our hypothesis that the adoptive transfer of NK cells could reduce the burden of viral infection through the elimination of infected epithelial cells, coordinate a more effective immune response, and result in a clinical benefit in patients with severe viral infection.