MiNK Therapeutics, a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic iNKT cell therapies for cancer and immune disorders, and First Lviv Territorial Medical Union today announced the initiation of a randomized Phase 2 clinical trial evaluating agenT-797, MiNK's off-the-shelf allogeneic invariant natural killer T cell therapy (iNKTs), in patients with severe acute lung injury (ALI). The study has received authorization from the Ministry of Health of Ukraine and is supported by an active U.S. IND.

The trial, designated C-1300-02, is a randomized, placebo-controlled study evaluating agenT-797 plus standard of care compared with placebo plus standard of care in patients with ALI meeting Global ARDS criteria. The study is designed to evaluate whether treatment with donor-derived iNKT cells may improve clinically meaningful outcomes in critically ill patients, including survival, ventilator-free days, ICU recovery, pathogen control, and reduction of secondary infections.