A Phase 1 interventional study of OrcaGraft (Orca-Q) in Acute Myeloid Leukemia, Myelodysplastic Syndromes and Mixed Phenotype Acute Leukemia, sponsored by Orca Biosystems, Inc.. Recruiting at 12 sites in United States. Open to participants aged 12 Years to 78 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Orca Biosystems, Inc. · Phase 1, Interventional, and Treatment
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.
Key Inclusion Criteria:
Age at the time of enrollment:
Key Exclusion Criteria:
Recipients with human leukocyte antigen (HLA)-identical related or unrelated or 1-allele mismatched (7/8 alleles) unrelated donor undergoing myeloablative conditioning (MAC); with single- or dual-agent graft-versus-host disease (GVHD) prophylaxis given
Biological: OrcaGraft (Orca-Q)
Recipients with haploidentical-related donors undergoing MAC; with single- or dual-agent GVHD prophylaxis given
Biological: OrcaGraft (Orca-Q)
Recipients with an HLA-identical related or unrelated donor undergoing MAC; no GVHD prophylaxis given
Biological: OrcaGraft (Orca-Q)
Recipients with an HLA-identical related or unrelated donor undergoing non-myeloablative (NMA)/reduced intensity conditioning (RIC); with dual agent GVHD prophylaxis given
Biological: OrcaGraft (Orca-Q)
Recipients with 1-allele mismatched (7/8 alleles) unrelated donor undergoing NMA/RIC; with dual-agent GVHD prophylaxis given
Biological: OrcaGraft (Orca-Q)
Recipients with haploidentical-related donors undergoing NMA/RIC; with dual-agent GVHD prophylaxis given
Biological: OrcaGraft (Orca-Q)
engineered donor allograft
Dose Limiting Toxicities through Day +28 (dose escalation)
Safety and tolerability of Orca-Q (formerly OrcaGraft) in adults undergoing myeloablative allogeneic hematopoietic cell transplantation (MA-alloHCT) will be evaluated by identification of the following dose limiting toxicities: Grade ≥ 3 infusion-related reaction or cytokine release syndrome, Grade ≥ 3 acute GVHD, Any Grade ≥ 3 treatment-related non-hematologic event not clearly related to the underlying malignancy, intercurrent infection, the HCT conditioning regimen, or other pre-existing medical condition
Time frame: 28 Days after administration of Orca-Q/OrcaGraft
Primary Graft failure through Day +28 (dose expansion)
Primary graft failure in the dose expansion phase, defined as being alive without recovery of neutrophils during the evaluation period
Time frame: 28 Days after administration of Orca-Q/OrcaGraft
Neutrophil Engraftment through Day +28
Neutrophil engraftment defined as an absolute neutrophil count of \>/=500/mm3 for 3 consecutive days
Time frame: 28 days after administration of Orca-Q/OrcaGraft
Platelet Engraftment through Day +50
Platelet engraftment is defined as achieving a platelet count \> 20,000/mm3 for 3 consecutive days without platelet transfusion in the preceding 7 days, by Day +50
Time frame: 50 days after administration of Orca-Q/OrcaGraft
Secondary Graft Failure through Day +100
Secondary graft failure is defined as neutrophil engraftment followed by subsequent decline in absolute neutrophil counts \< 500 cells/μL, unresponsive to growth factor therapy, by Day +100
Time frame: 100 days after administration of Orca-Q/OrcaGraft
Acute GVHD through Day +100
Acute GVHD will be staged and graded per Mount Sinai Acute GvHD International Consortium (MAGIC) Standardization criteria
Time frame: 100 days after administration of Orca-Q/OrcaGraft
Chronic GVHD through Day +365
Chronic GVHD will be diagnosed per 2014 International NIH Chronic GVHD Diagnosis and Staging Consensus Working Group criteria
Time frame: 365 days after administration of Orca-Q/OrcaGraft
Incidence of Non-relapse Mortality (NRM) through Day +365
NRM is defined as death without evidence of disease recurrence
Time frame: 365 days after administration of Orca-Q/OrcaGraft
Incidence of Disease Relapse through Day +365
Recurrence of primary disease for transplant
Time frame: 365 days after administration of Orca-Q/OrcaGraft
GVHD-free and Relapse-free Survival (GRFS) through Day +365
Survival free from GVHD and relapse
Time frame: 365 days after administration of Orca-Q/OrcaGraft
Disease-free Survival (DFS) through Day +365
DFS is the time from date of transplant to death or relapse, whichever comes first.
Time frame: 365 days after administration of Orca-Q/OrcaGraft
Overall Survival through Day +365
OS is defined as the time from the date of transplant to the date of death from any cause or, for surviving patients, to the date of last follow-up.
Time frame: 365 days after administration of Orca-Q/OrcaGraft
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Orca Biosystems, Inc.