zedenoleucel (MT-401)

P2, N=47, Completed, Marker Therapeutics, Inc. | Active, not recruiting --> Completed | N=180 --> 47 | Trial completion date: Aug 2024 --> Mar 2024

P2, N=180, Active, not recruiting, Marker Therapeutics, Inc. | Trial completion date: Jul 2027 --> Aug 2024 | Trial primary completion date: Jul 2024 --> Mar 2024

P2, N=180, Active, not recruiting, Marker Therapeutics, Inc. | Recruiting --> Active, not recruiting

Interestingly, the tumor antigen composition by RNASeq identified an antigen expression profile that changes over time and inversely correlates with the presence of antigen-specific T cells, demonstrating the interplay of tumor cell immunogenicity and antigen-specific T cells. Conclusion s : The preliminary ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRD- indicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be beneficial.

The lead-in portion of the ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRD-indicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be beneficial.

The lead-in portion of the ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRDindicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be benefi cial.

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.