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
- 1. First allogeneic HSCT, in > Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as patients with CRMRD by central testing; and are MRD negative pre-transplant by local or central testing ; or Treatment for relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as:
- First relapse (MRD+ or frank relapse) post-HSCT
- Patients in Group 1 who are randomized to Arm 1B (SOC) and experience first relapse (MRD+ or frank relapse) post-HSCT or experience relapse prior to randomization.
- Patients with frank relapse will enter into Subgroup C while patients with MRD+ disease will enter into Subgroup D
- Safety Lead-in (Cohorts I and II) and Cohorts III-V defined as patients whose prior treatment course does not meet precise eligibility criteria but may still be approved upon review by the Sponsor as described for Group 2 only
- 2. Are >18 years of age
- 3. Karnofsky/Lansky score of >60
- 4. Life expectancy >12 weeks
- 5. Adequate blood, liver, and renal function as defined by protocol
- 6. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.
- 7. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit
- 1. Clinically significant or severely symptomatic intercurrent infection
- 2. Pregnant or lactating
- 3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
- 4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
- 5. Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401
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