Tests Orca-Q donor graft in people receiving stem cell transplants for blood cancers
Tests an engineered donor graft in people having transplants for blood cancers.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Key facts
- Where
- Atlanta, Columbus, Duarte, Hackensack, Houston, Kansas City, Milwaukee, New York, Sacramento, Seattle, Stanford, and Tampa, United StatesSee the 12 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with certain blood cancers who need a donor stem cell transplant. They receive a donor graft called Orca-Q.
- Age
- 12 to 78 years. For some mismatched-donor arms, 12 to 65 years.
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid, lymphoblastic or mixed phenotype leukemia, or high or very high risk myelodysplastic syndrome. Disease in complete remission or with 10 percent or fewer blast cells in bone marrow. A donor stem cell transplant must be needed.
- Earlier treatment
- People who had an earlier donor stem cell transplant cannot join. Planned donor lymphocyte infusion or planned T cell depletion drugs are not allowed.
- Biomarker or test result
- A related or unrelated donor with 8/8 or 7/8 matching tissue type, or a related half-matched (haploidentical) donor. No anti-donor HLA antibodies against a mismatched allele.
Main reasons for not taking part
- Earlier donor stem cell transplant
- Taking steroids above 10 mg/day or other immune-suppressing therapy
- Uncontrolled infection, or HIV, HTLV or hepatitis B or C positive
- Other cancer within 1 year, or history of myelofibrosis
- Pregnant or breastfeeding
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 78 years old?
Source: NCT03802695, who can take part
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- Ohio State UniversityColumbus, United StatesNo longer taking part
- City of HopeDuarte, United StatesTaking people
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- The University of Kansas HospitalKansas City, United StatesNo longer taking part
- Froedtert Memorial Lutheran HospitalMilwaukee, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- UC DavisSacramento, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Stanford Health CareStanford, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orca Biosystems, Inc.
- Trial code
- NCT03802695
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age at the time of enrollment:; For MAC with fully matched donor (Arm A with 8/8 donor and Arm C) and NMA/RIC: Age ≥ 12 and ≤ 78 years; For MAC with mismatched donors (Arm A with 7/8 donor and Arm B): Age ≥ 12 and ≤ 65 years; Diagnosed acute myeloid, lymphoblastic or mixed phenotype leukemia, or high or very high risk myelodysplastic syndrome (MDS) either in complete remission (CR) or with ≤ 10 percent of blast cells in bone marrow (BM); Indicated for allogeneic hematopoietic stem cell transplant (alloHCT); Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor; Estimated glomerular filtration rate (eGFR) > 50 mL/minute (MAC with tacrolimus) or > 30 mL/minute (NMA/RIC or MAC without tacrolimus); Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC); Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC; Liver function: Total bilirubin < 1.5 times upper limit of normal (ULN) (MAC) or < 3 times ULN (NMA/RIC); alanine transaminase (ALT)/aspartate transaminase (AST) < 3 times ULN (MAC) or < 5 times ULN (NMA/RIC); Participants enrolling on NMA/RIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI).
Exclusion: Prior alloHCT; Currently receiving corticosteroids or other immunosuppressive therapy except for approved disease-specific therapy for the patient's underlying hematologic malignancy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed; Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab; Positive anti-donor HLA antibodies against a mismatched allele in the selected donor; Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment; Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected. Patients with concurrent indolent hematologic malignancies that do not require active treatment and are under active surveillance only (such as CLL, low-grade lymphomas, smoldering MM, MZL) may be included with the approval of Medical Monitor; Seropositive for human immunodeficiency virus (HIV)-1 or -2, human T-lymphotropic virus (HTLV)-1 or -2 or Hepatitis B surface antigen (HbsAg) or anti-Hepatitis C virus (HCV) antibody (Ab); Any uncontrolled autoimmune disease requiring active immunosuppressive treatment; History of idiopathic or secondary myelofibrosis; Planned donor lymphocyte infusion (DLI); Low performance score: For MAC: Karnofsky Performance Score (KPS) < 70 percent, For NMA/RIC: <60 percent; High HCT-specific Comorbidity Index (HCT-CI): For MAC > 4, For NMA/RIC >6; Women who are pregnant or breastfeeding.