Actively Recruiting
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Led by Orca Biosystems, Inc. · Updated on 2026-02-23
300
Participants Needed
9
Research Sites
451 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.
CONDITIONS
Official Title
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 78 years for fully matched donors or non-myeloablative/reduced intensity conditioning
- Age between 12 and 65 years for mismatched donors with myeloablative conditioning
- Diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia, or high/very high risk myelodysplastic syndrome in complete remission or with 40% bone marrow blasts
- Eligible for allogeneic hematopoietic stem cell transplant
- Matched to an 8/8 or 7/8 related or unrelated donor, or a related haploidentical donor
- Estimated glomerular filtration rate above 50 mL/min for myeloablative conditioning with tacrolimus, or above 30 mL/min for non-myeloablative/reduced intensity conditioning or myeloablative conditioning without tacrolimus
- Cardiac ejection fraction at least 45% for myeloablative conditioning or at least 40% for non-myeloablative/reduced intensity conditioning
- Lung diffusing capacity for carbon monoxide adjusted for hemoglobin at least 50% for myeloablative conditioning or at least 40% for non-myeloablative/reduced intensity conditioning
- Liver function with total bilirubin less than 1.5 times upper limit of normal for myeloablative conditioning or less than 3 times upper limit for non-myeloablative/reduced intensity conditioning; ALT/AST less than 3 times upper limit for myeloablative conditioning or less than 5 times upper limit for non-myeloablative/reduced intensity conditioning
- For non-myeloablative/reduced intensity conditioning arms, participants must be deemed unfit for myeloablative transplant by the principal investigator
You will not qualify if you...
- Previous allogeneic hematopoietic cell transplant
- Currently receiving corticosteroids or immunosuppressive therapy except approved disease-specific treatment; topical corticosteroids or oral corticosteroids up to 10 mg/day allowed
- Planned donor lymphocyte infusion
- Planned pharmaceutical T cell depletion such as post-transplant cyclophosphamide or alemtuzumab
- Presence of anti-donor HLA antibodies against mismatched donor alleles
- Low performance score: Karnofsky score below 70% for myeloablative conditioning or below 60% for non-myeloablative/reduced intensity conditioning
- High hematopoietic cell transplant-specific comorbidity index: above 4 for myeloablative conditioning or above 6 for non-myeloablative/reduced intensity conditioning
- Uncontrolled infections with ongoing antimicrobial therapy and no improvement
- Positive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B surface antigen, or Hepatitis C antibody
- Uncontrolled autoimmune disease requiring active immunosuppressive treatment
- Concurrent malignancies or active disease within 1 year except certain non-melanoma skin cancers and some indolent hematologic malignancies under surveillance with approval
- History of idiopathic or secondary myelofibrosis
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
3
Stanford Health Care
Stanford, California, United States, 94305
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
6
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Withdrawn
7
Ohio State University
Columbus, Ohio, United States, 43210
Active, Not Recruiting
8
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77054
Actively Recruiting
9
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Withdrawn
Research Team
T
Tamara Zharkevich, MD, PhD
CONTACT
J
James S McClellan, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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