Initiation of the phase I/II ReSET-02 trial of SMART101 for the treatment of AML

On September 27, 2023, it was announced that the first two patients had been dosed in the multicenter, open-lab, dose-escalation, phase I/II ReSET-02 trial (NCT05768035).¹

This trial will assess the safety and efficacy of SMART101, an allogeneic cell therapy produced from donor-mobilized peripheral blood stem cells differentiated into T-cell progenitors, in adult patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndromes (MDS) who are eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a haploidentical donor with post-transplant cyclophosphamide.¹

SMART101 has previously been granted orphan drug designation by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), and fast-track designation by the FDA, for the treatment of patients undergoing allo-HSCT.¹

In total, 40 patients are planned to be enrolled in the trial, with the phase II portion consisting of two parallel cohorts according to the intensity of conditioning chemotherapy.¹ Preliminary data suggest that SMART101 is well tolerated, with the safety profile as expected.¹