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). <\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
In April 2020, the FDA granted Orphan Drug designation to MT-401 for the treatment of patients with AML following allogeneic stem cell transplant. <\/p>\n