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