Safety Lead-In of Ph2 AML Study Results Using Zedenoleucel (ASGCT 2022)
Zedenoleucel (also known as MT-401) is a non-genetically modified allogeneic multi-tumor associated antigen (mTAA)-specific T cell therapy with selectivity to multiple tumor antigens, PRAME, WT1, NY-ESO-1 and Survivin... Zedenoleucel was successfully manufactured using two different reagent vendors and was safely administered to 6 post-transplant AML patients with no DLTs noted. Preliminary evidence of anti-tumor activity with zedenoleucel was observed in the Safety Lead-in portion of the Phase 2 ARTEMIS study which further supports the promising Phase 1 ADSPAM data using mTAA-specific T cells. Specifically, the ARTEMIS results showed that administration of zedenoleucel converted an MRD+ patient to MRD- and suggests that AML patients could potentially benefit from administration of zedenoleucel.