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A Study of Engineered Donor Grafts (TregGraft/Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Cancer Type
Trial Phase
Phase I
18 - 65 Years, Male and Female
Study Type
Protocol IDs
TRGFT-201 (primary)
Study Sponsor
Orca Biosystems, Inc.


This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft
("TregGraft"/"Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T
Cells and Regulatory T Cells) in participants undergoing myeloablative allogeneic
hematopoietic cell transplant transplantation for hematologic malignancies.


  1. Key Inclusion Criteria: Recipients must meet all of the following criteria: 1. Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned: - acute myeloid, lymphoid or mixed phenotype leukemia - high or very high risk myelodysplastic syndromes - Myelofibrosis - Blastic Plasmacytoid Dendritic Cell Neoplasm 2. Patients with active acute leukemia (i.e. not in morphologic complete response) must have bone marrow infiltration by leukemic blasts of <= 10%, 3. Patients must be matched to a related or unrelated donor 4. Estimated glomerular filtration rate (eGFR) > 50 mL/minute 5. Cardiac ejection fraction at rest = 45% or shortening fraction of = 27% by echocardiogram or radionuclide scan (MUGA) 6. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) = 50% 7. Total bilirubin < 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST < 3 times ULN Key Exclusion Criteria: Recipients meeting any of the following exclusion criteria will not be eligible: 1. History of prior allogeneic HCT 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. Pre-planned donor lymphocyte infusion (DLI) 4. Planned pharmaceutical in vivo or ex vivo T cell depletion 5. Positive for anti-donor HLA antibodies against an allele in the selected donor 6. Karnofsky performance score < 70% 7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment 9. Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody 10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment 11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected 12. Women who are pregnant or breastfeeding
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.