Immuno-oncology company Marker Therapeutics, Inc. (MRKR) announced Tuesday that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on its Phase 2 trial investigating the safety and efficacy of MT-401, Marker's lead multi-tumor-associated antigen (MultiTAA)-specific T cell product candidate for the treatment of post-transplant acute myeloid leukemia (AML).
With the FDA's decision, Marker will now be able to seamlessly enroll patients in the second half of the safety lead-in, as well as the remainder of the Phase 2 AML trial of MT-401, which is expected to provide a safe and effective treatment option for patients with post-transplant AML over the standard of care.
The multicenter Phase 2 AML study is evaluating clinical efficacy of MT-401 in patients with AML in both the adjuvant and active disease setting, following an allogeneic stem-cell transplant.
In the adjuvant setting, approximately 120 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation, while about 40 patients with active disease will receive MT-401 as part of the single-arm group.
The primary objectives of the trial are to evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients.
In April 2020, the FDA granted Orphan Drug designation to MT-401 for the treatment of patients with AML following allogeneic stem cell transplant.
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