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A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients with Acute Myeloid Leukemia (AML) following Hematopoietic Stem Cell Transplantation
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).
Primary: Safety Lead-in: To assess safety and tolerability of MT-401 Phase 2: Adjuvant (Group 1): To compare relapse-free survival (RFS) for MT-401 (Arm A) vs standard of care (SOC; Arm B) Active Disease (Group 2): To estimate complete remission (CR) and duration of CR (DOCR) Secondary (Efficacy): Safety Lead in: To assess efficacy of MT-401 Phase 2 (Adjuvant Group 1): >To analyze overall survival (OS) for MT-401 (Arm A) and SOC (Arm B); >To compare graft-versus-host disease RFS (GRFS) for MT-401 (Arm A) vs SOC (Arm B). Phase 1 (Active Disease Group 2): >To evaluate overall response rate (ORR), duration of complete remission (DOR), progression-free survival (PFS) and OS for MT 401 alone; > To evaluate RFS, OS, and GRFS for patients who achieve CR following bridging therapy. Secondary (Safety): Phase 2 (Groups 1 and 2): >To evaluate the safety and tolerability of administering donor-derived MT 401 to patients with AML post-HSCT