In recent years, immunotherapy has revolutionized cancer treatment, offering increasingly effective and personalized solutions. Among the most promising innovations are induced pluripotent stem cells (iPSCs), which enable the development of accessible and tailored therapies. In this context, FT596 stands out as a true breakthrough: a therapy based on natural killer (NK) cells derived from iPSCs, designed to fight relapsed or refractory B-cell lymphoma.

The key role of NK cells

Natural killer (NK) cells are a fundamental component of our immune system. They act as true sentinels, capable of identifying and destroying abnormal cells, such as those infected by viruses or transformed into tumors. Unlike other lymphocytes, NK cells do not require specific instructions to take action: they detect the threat and eliminate it immediately.

Thanks to advances in research, we can now produce these cells in the laboratory starting from iPSCs. This has opened the way to off-the-shelf cell therapies, without the limitations of donor availability and the challenges related to patient compatibility.

How does FT596 work?

FT596 has been designed to fight B-cell lymphoma through a combined approach. The first key element is the CAR-CD19 receptor, which enables NK cells to precisely recognize and attack tumor cells. This is complemented by a CD16 Fc receptor, which enhances the cytotoxic activity of NK cells. Finally, the presence of interleukin-15 (IL-15) ensures greater cell persistence and prolonged activity within the body.

This therapy can be used alone or in combination with rituximab, a drug already widely used in the treatment of lymphomas.

Encouraging results from clinical studies

A recent study tested FT596 in 86 patients with advanced B-cell lymphoma, divided into two groups: some received FT596 alone, while others were treated in combination with rituximab. Before receiving the therapy, all patients underwent a conditioning chemotherapy regimen to prepare the body for treatment.

The results obtained are very promising. FT596 was well tolerated, and none of the patients reached the maximum tolerated dose, indicating an excellent safety profile. Side effects were limited: cytokine release syndrome (CRS), an inflammatory reaction typical of immunotherapies, occurred in a small number of patients and in mild form, while no cases of neurotoxicity—a common issue with similar therapies—were reported.

A particularly interesting aspect concerns patients who had previously received CAR-T cell therapy without success. FT596 proved to be a valid alternative for them as well, opening new prospects for those who did not respond to prior treatments.

For phase 2 of the study, the optimal dose (RP2D) was set at 1.8 × 10⁹ cells per dose, administered in three doses per cycle.

A step forward in immunotherapy

This new therapy could mark a turning point in cancer treatment. Compared to personalized CAR-T therapies, FT596 offers several advantages: faster production times, greater availability thanks to large-scale manufacturing, and a more consistent therapy with less variability between patients

EternaCell and the future of regenerative medicine

EternaCell closely follows developments in the fields of regenerative medicine and immunotherapy. The use of NK cells derived from iPSCs, as demonstrated with FT596, could represent a crucial breakthrough in the fight against cancer, offering safer, more accessible, and more effective treatments.

With continuous advances in research, immunotherapy is opening new possibilities for tackling even the most complex forms of cancer, offering hope to an increasing number of patients.