Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Exclusion Criteria

• •1. Prior alloHCT
• •2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
• •3. Planned donor lymphocyte infusion (DLI)
• •4. Planned pharmaceutical in vivo or ex vivo T-cell depletion
• •5. Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor
• •6. Karnofsky performance score \<60%
• •7. For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6
• •8. Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment
• •9. Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative
• •10. Known allergy or hypersensitivity to or intolerance of tacrolimus
• •11. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal, or Streptomyces avidinii proteins
• •12. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
• •13. Concurrent malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected
• •14. Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care
• •15. Persons who are pregnant or breastfeeding
• •16. Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation.
• •17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which could affect compliance with the protocol or interpretation of results