AgenT-797 is a scalable, donor-unrestricted allogeneic iNKT cell therapy. Preclinically, iNKT can treat various diseases directly and by activating host immunity, reverse T cell exhaustion, activate dendritic cells and preferentially kill M2 macrophages. agenT-797 is a promising immunotherapy for multiple diseases and a rational combination with checkpoint inhibitors for cancer patients who progress on anti-PD-1 therapy. We have previously reported data from a myeloma clinical trial. We now report 2 further trials. Solid Tumor Trial: 34 patients with relapsed or refractory solid tumor malignancies were treated with agenT-797 monotherapy (n=28) or in combination with PD-1 mab (n=6) in a 3+3 dose escalation scheme (NCT05108623). Endpoints included safety, persistence of agenT-797, clinical responses and progression-free survival. Patients had median of 3 prior lines of therapy. No dose limiting toxicities were observed. Tolerability was favorable with no cytokine release syndrome (CRS), neurotoxicity, or severe immune related adverse events. Evidence of clinical benefit included tumor shrinkage, objective response in PD-1 refractory cancers and disease stabilization in heavily pretreated relapsed, refractory cancers and tumors refractory to ICI therapy. COVID-19 Trial: We conducted an open-label study in virally-induced acute respiratory distress syndrome (ARDS) caused by SAR-Cov-2 (NCT04582201). In 21 ventilated patients including 5 individuals receiving veno-venous extracorporeal membrane oxygenation (VV-ECMO), there were no dose-limiting toxicities. We observed an anti-inflammatory systemic cytokine response and infused iNKT cells were persistent during follow-up, inducing only transient donor-specific antibodies. Clinical signals of improved survival and prevention of secondary infections were evident. Conclusions: We report interim results on drug product safety and antigenicity, peripheral and tissue persistence of agenT-797 in the absence of lymphodepletion, and the impact of treatment on serum biomarkers and the TME. Cellular therapy using off-the-shelf iNKT cells is safe, can be rapidly scaled and is associated with an anti-tumor and anti-inflammatory response. Therapeutic potential of iNKT cells across diseases including infections and cancer warrants randomized-controlled trials.