AgenT-797

Overview

AgenT-797 is an investigational, off-the-shelf cell therapy made from invariant natural killer T (iNKT) cells collected from healthy donors and expanded in the laboratory. It has been studied in solid tumors and in acute respiratory distress syndrome (ARDS). The human results available so far come mainly from small, early-stage studies; clinical benefit has not been established. (nature.com)

Mechanism of action

The infused cells are unmodified. Their receptors recognize lipid antigens presented by CD1d; iNKT cells can also recognize other signals on abnormal cells. The proposed effects include direct tumor-cell killing and regulation of other immune cells, including T cells and antigen-presenting cells. In ARDS, researchers are investigating whether these cells can alter harmful inflammation and support antimicrobial immunity. (nature.com)

Efficacy

• Solid tumors: An updated phase 1 abstract reported a complete remission in one patient with metastatic testicular cancer treated with agenT-797 plus anti-PD-1 therapy, a confirmed partial response in one patient with gastric cancer, and disease stabilization in nine others. These observations do not establish an overall response rate or show how much benefit was attributable to agenT-797. (jitc.bmj.com)
• Gastroesophageal cancer: In a phase 2 study combining agenT-797 with two checkpoint inhibitors and chemotherapy/ramucirumab, 0 of 15 patients with measurable disease had a complete or partial response; 11 of 15 (73%) had stable disease. Median progression-free survival was 4.4 months. The investigators reported no improvement in response rate or median survival outcomes against historical comparisons. (aacrjournals.org)
• COVID-19–related ARDS: In an open-label phase 1/2 study, 14 of 20 (70%) mechanically ventilated trial participants survived after treatment. Without a randomized comparison, survival cannot be attributed to agenT-797. (nature.com)

Safety

The phase 1 solid-tumor abstract reported no new safety signals with agenT-797 alone or alongside anti-PD-1 therapy. In the ARDS study, there were no dose-limiting toxicities or observed cytokine-release syndrome; one patient had a possible grade 4 treatment-related episode of breathing difficulty. In the five-drug gastroesophageal regimen, all 17 patients had an adverse event and 9 (53%) had a grade 3 or higher event; those findings cannot be assigned to agenT-797 alone. (jitc.bmj.com)

Further reading

• Peer-reviewed ARDS phase 1/2 study
• Updated solid-tumor phase 1 conference abstract
• Gastroesophageal cancer phase 2 conference abstract

Last updated: Sep 2026