Status:
RECRUITING
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Lead Sponsor:
Orca Biosystems, Inc.
Conditions:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for ...
Detailed Description
This study is a multicenter, open-label phase 2 trial of Orca-T in adults with acute myeloid leukemia or myelodysplastic syndrome who are not able to receive myeloablative (high intensity) conditionin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07216443
Start Date
December 9 2025
End Date
December 1 2028
Last Update
January 8 2026
Active Locations (4)
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1
UCLA Department of Medicine
Los Angeles, California, United States, 90095
2
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37221