Final Dose Phase of ReSET-02 Trial in Adult Leukemia

Smart Immune, a biotech firm specializing in the development of ProTcell, a novel T cell therapy designed to enhance the immune system's response to cancer and infections, has reached a significant phase in its clinical trials. The company has administered the final dose in the dose-escalation phase of the ReSET-02 trial to an adult patient suffering from acute leukemia. This marks a pivotal step in assessing the effectiveness of SMART101, a therapy aimed at post-transplant hematology.

The ReSET-02 trial, an open-label, multi-center study, is focused on evaluating the safety and efficacy of SMART101 in adult patients with acute lymphoid leukemia who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) followed by post-transplant cyclophosphamide (PTCy). The trial has successfully moved to the final dose level due to the positive safety outcomes observed in earlier cohorts. SMART101 is engineered to expedite the reconstitution of T cells, which could potentially combat relapse and infection, thereby improving survival rates post-transplant.

Karine Rossignol, CEO and Co-founder of Smart Immune, expressed enthusiasm for the milestone, highlighting the therapy's excellent safety profile and the absence of dose-limiting toxicities in the initial dose levels. The final dose level is a crucial step towards the company's goal of resetting the immune system with a new T cell compartment to enhance clinical outcomes for patients with high-risk cancers. Preliminary data on immune reconstitution, even among patients aged 50-70, are promising.

No safety events have been reported in the ReSET-02 trial, which aligns with the positive safety profiles from other Smart Immune-sponsored trials across Europe and the US. SMART101, derived from healthy donor stem cells, has received Orphan Drug Designation from both the European Medicines Agency and the US FDA, as well as Fast Track Designation from the FDA, underscoring its potential to improve clinical outcomes for patients undergoing allo-HSCT.

Smart Immune is dedicated to revolutionizing outcomes for patients in the fields of hematology and immuno-oncology with its ProTcell platform. SMART101 is currently in Phase I/II trials for patients with acute leukemia or severe combined immunodeficiencies in both the EU and the US, with plans to explore additional clinical applications in combination with innovative cancer therapies.