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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Age ≥18 years at the time of enrollment
• Diagnosed with 1 of the following diseases:
• Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease.
• Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and/or therapy-related/secondary MDS as defined by the World Health Organization (WHO) classification of myeloid malignancies, with ≤10% blast burden in the bone marrow.
• Planned to undergo 1 of the following preparative regimens as per Investigator discretion:
• RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI/thiotepa/fludarabine
• NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine/cyclophosphamide/TBI
• Identified related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and -DRB1
• Estimated glomerular filtration rate ≥30 mL/minute
• Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA)
• Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%
• Negative serum or urine β-HCG test in persons of childbearing potential
• Alanine transaminase (ALT)/aspartate transaminase (AST) <5 times the upper limit of normal (ULN)
• Total bilirubin <3 × ULN
• Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator

You cannot join if

• Prior alloHCT
• Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
• Planned donor lymphocyte infusion (DLI)
• Planned pharmaceutical in vivo or ex vivo T-cell depletion
• Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor
• Karnofsky performance score <60%
• For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6
• Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment
• 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
• Known allergy or hypersensitivity to or intolerance of tacrolimus
• Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal, or Streptomyces avidinii proteins
• Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
• Concurrent malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected
• Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care
• Persons who are pregnant or breastfeeding
• 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.
• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Orca-T (Biological): An allogeneic stem cell and T-cell immunotherapy biologic

Non Randomized · Single Group · masking: None

Main goals

• RIC Cohort: GVHD-free and relapse-free survival (GRFS) (Day 0 through day +365 after transplantation)
• NMA Cohort: Incidence of neutrophil engraftment (Day 0 through day +28 after transplantation)
• NMA Cohort: Time to neutrophil engraftment (Day 0 through day +28 after transplantation)

Other goals

• Safety of Orca-T
• Incidence of serious infections
• Severity of serious infection
• Overall survival
• Non-relapse mortality
• Relapse-free survival
• Chronic GVHD-free survival
• GVHD-free and relapse-free survival (GRFS)
• Incidence of acute GVHD
• Severity of acute GVHD
• Time to onset of acute GVHD
• Incidence of chronic GVHD
• Severity of chronic GVHD
• Time to onset of acute GVHD
• RIC cohort: Incidence of neutrophil engraftment
• RIC cohort: Time to neutrophil engraftment
• Incidence of platelet engraftment
• Time to platelet engraftment
• Incidence of steroid-refractory acute GVHD
• Incidence of steroid-refractory chronic GVHD

Planned enrollment: 80 (estimated).

• UCLA Department of Medicine, Los Angeles, California
• Moffitt Cancer Center, Tampa, Florida
• John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey
• Weill Cornell Medicine - New York Presbyterian Hospital, New York, New York
• Oregon Health and Science University, Portland, Oregon
• Vanderbilt University, Ingram Cancer Center, Nashville, Tennessee

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07216443

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 6, 2026. Public record; not medical advice.