Actively Recruiting
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Led by Orca Biosystems, Inc. · Updated on 2026-04-15
80
Participants Needed
5
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).
CONDITIONS
Official Title
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at enrollment
- Diagnosed with acute myeloid leukemia or mixed phenotype leukemia in complete remission or remission with incomplete hematologic recovery, with or without minimal residual disease
- Diagnosed with myelodysplastic syndrome indicated for alloHCT per expert panel recommendations or therapy-related/secondary MDS with 10% or less blast cells in bone marrow
- Planned to receive reduced intensity conditioning (RIC) or non-myeloablative (NMA) alloHCT preparative regimen as chosen by the investigator
- Identified an 8/8 HLA-matched related or unrelated donor
- Estimated glomerular filtration rate of 30 mL/minute or higher
- Cardiac ejection fraction at rest of 40% or greater or shortening fraction of 22% or greater
- Lung diffusing capacity for carbon monoxide of 40% or greater
- Negative pregnancy test if of childbearing potential
- Liver enzymes (ALT/AST) less than five times upper normal limit
- Total bilirubin less than three times upper normal limit
- Deemed ineligible for fully myeloablative alloHCT by principal investigator
You will not qualify if you...
- Prior allogeneic hematopoietic cell transplantation
- Currently receiving corticosteroids or other immunosuppressive therapy above 10 mg/day oral corticosteroids; topical corticosteroids allowed
- Planned donor lymphocyte infusion
- Planned pharmaceutical in vivo or ex vivo T-cell depletion
- Presence of recipient-positive antidonor HLA antibodies against mismatched donor allele
- Karnofsky performance score less than 60%
- For RIC cohort: Hematopoietic Cell Transplantation Comorbidity Index of 6 or higher
- Uncontrolled bacterial, viral, or fungal infection with progression or no improvement while on antimicrobial therapy
- Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or hepatitis C antibody unless treated and HCV NAT negative
- Known allergy or intolerance to tacrolimus
- Allergy or hypersensitivity to iron dextran or certain animal or microbial proteins
- Uncontrolled autoimmune disease requiring active immunosuppressive treatment
- Other cancers within one year except curatively resected nonmelanoma skin cancer
- Psychosocial conditions preventing transplantation or follow-up participation
- Pregnant or breastfeeding persons
- Persons of childbearing potential or men with partners of childbearing potential unwilling to use effective birth control or abstinence for one year post-transplant
- Serious medical conditions or lab abnormalities precluding safe participation or affecting protocol compliance or results interpretation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
UCLA Department of Medicine
Los Angeles, California, United States, 90095
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
5
Vanderbilt University, Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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