Actively Recruiting
A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
Led by Orca Biosystems, Inc. · Updated on 2026-06-02
300
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of engineered donor grafts called OrcaGraft or Orca-Q in people undergoing allogeneic hematopoietic cell transplantation (alloHCT) for blood cancers like acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia, and high-risk myelodysplastic syndromes. This phase 1 trial aims to understand how well these specialized grafts work and how safe they are for patients receiving this transplant treatment. Participants will receive OrcaGraft (Orca-Q), an engineered donor allograft derived from mobilized peripheral blood. The study includes several groups based on donor matching and conditioning regimens, such as myeloablative conditioning (MAC) or non-myeloablative/reduced intensity conditioning (NMA/RIC). Some groups receive single or dual-agent graft-versus-host disease (GVHD) prevention treatments, while others do not. Different types of donors are included, such as fully matched, mismatched, and haploidentical donors. During the study, researchers will monitor participants closely for dose-limiting toxicities and primary graft failure within 28 days after treatment. They will also track neutrophil and platelet engraftment, graft failure, acute and chronic GVHD, non-relapse mortality, disease relapse, survival rates, and GVHD-free relapse-free survival for up to one year. Patients will have regular evaluations and safety assessments throughout this period, providing detailed information about the treatment effects and potential risks over time.
CONDITIONS
Brief 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 myeloablative conditioning with fully matched donor and non-myeloablative/reduced intensity conditioning
- Age between 12 and 65 years for myeloablative conditioning with mismatched donors
- Diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia, or high/very high risk myelodysplastic syndrome in complete remission or with ≤10% bone marrow blasts
- Indicated for allogeneic hematopoietic stem cell transplant
- Matched 8/8 or 7/8 related or unrelated donor, or related haploidentical donor available
- Estimated glomerular filtration rate >50 mL/min for myeloablative conditioning with tacrolimus or >30 mL/min otherwise
- Cardiac ejection fraction ≥45% for myeloablative conditioning or ≥40% for non-myeloablative/reduced intensity conditioning
- Lung diffusing capacity (DLCO) adjusted for hemoglobin ≥50% for myeloablative conditioning or ≥40% for non-myeloablative/reduced intensity conditioning
- Liver function within specified limits depending on conditioning regimen
- For non-myeloablative/reduced intensity conditioning arms, participant must be deemed unfit for myeloablative transplant by the principal investigator
You will not qualify if you...
- Prior allogeneic hematopoietic cell transplant
- Current use of corticosteroids or immunosuppressive therapy except approved disease-specific treatments; topical or ≤10 mg/day oral corticosteroids allowed
- Planned donor lymphocyte infusion
- Planned pharmaceutical T cell depletion treatments such as post-transplant cyclophosphamide or alemtuzumab
- Presence of anti-donor HLA antibodies against mismatched donor allele
- Low performance status (Karnofsky Performance Score <70% for myeloablative conditioning; <60% for non-myeloablative/reduced intensity conditioning)
- High hematopoietic cell transplant-specific comorbidity index (HCT-CI >4 for myeloablative conditioning; >6 for non-myeloablative/reduced intensity conditioning)
- Uncontrolled infections not improving with therapy at enrollment
- Positive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or hepatitis C antibody
- Uncontrolled autoimmune disease needing immunosuppressive treatment
- Active malignancies within 1 year except certain non-melanoma skin cancers or stable indolent blood cancers 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 365 days after administration of OrcaGraft
Participants receive the OrcaGraft, an engineered donor allograft, as part of their allogeneic hematopoietic cell transplantation following conditioning regimens and graft-versus-host disease prophylaxis.
Visits occur frequently during the first 100 days and continue with assessments up to one year
Trial Site Locations
Total: 11 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
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Active, Not Recruiting
9
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77054
Actively Recruiting
10
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
11
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Withdrawn
Research Team
T
Tamara Zharkevich, MD, PhD
J
James S McClellan, MD PhD
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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