AML-109 Preliminary Results of MT-401 in Post-Transplant Measurable Residual Disease Positive (MRD+) Acute Myeloid Leukemia (AML) Patients

Shukaib Arslan, Jingmei Hsu, Betul Oran, Alejandro Sica, Hongtao Liu, Margarida Silverman, Nelli Bejanyan, Antonio DiStasi, Robin McCallum, Silvia Quintero, Gerald Garrett, Karrie Wang, Eric Smith, Tsvetelina Hoang, Tara Shahim, Jeannette Crisostomo, Anna Wilga-Savitski, Jennifer Pickering, Laura Angelo, Anastasiya SmithJuan Vera, Mythili Koneru

Research output: Contribution to journalArticlepeer-review


Context: Measurable residual disease (MRD) testing has become more prevalent in AML. MRD positivity is associated with increased relapse risk and shorter survival in AML and, currently, there are no approved therapies for these patients. Objective: To determine whether MRD+ patients post-allogeneic transplant can be treated safely and effectively with multi-tumor-associated antigen (mTAA)-specific T cells (MT-401/zedenoleucel) Design: A multicenter Phase 2 study (ARTEMIS) evaluating the safety and efficacy of MT-401 in patients with AML post-transplant is ongoing and includes patients with MRD+ disease. Patients: Three MRD+ AML patients were enrolled and treated in the ARTEMIS study. MRD testing was done by flow cytometry or molecular testing (e.g., RT-PCR). Interventions: Patients received up to 3 consecutive infusions of MT-401 as a monotherapy (50-200×106 cells every 2 weeks) at weeks 0, 2, and 4 during the Intervention Period, and entered Follow-up starting at Week 8 for up to 5 years. Main Outcome Measures: The primary endpoint includes various safety measurements and incidence of dose-limiting toxicities (DLTs). The secondary endpoint was efficacy evaluations using ELN recommendations for standard AML response criteria. Results: No DLTs were observed. The MRD+ patient had a variety of genetic mutations/abnormalities. One patient with NPM1 mutation converted from MRD+ to MRD- at week 8 evaluation. Another patient with RUNX1 genetic abnormality showed a decrease in MRD by PCR from a starting baseline of 0.8093% to resolution via peripheral blood at approximately 32 weeks post-treatment with MT-401. T cell receptor (TCR) analysis identified 3,117 antigen-specific clones (881 Survivin, 783 NY-ESO-1, 750 PRAME, 709 WT1). Immune monitoring of this patient showed T cell specificity not only for the targeted antigens but also for non-targeted antigens over time, thereby demonstrating epitope spreading. 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)S213-S214
JournalClinical Lymphoma, Myeloma and Leukemia
StatePublished - Oct 2022


  • acute myeloid leukemia
  • AML
  • measurable residual disease
  • MRD
  • mTAA-specific T cells
  • multi-tumor-associated antigen-specific T cells
  • Phase II

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research


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