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

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ClinicalTrials.gov Identifier: NCT04013685
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : January 26, 2023
Information provided by (Responsible Party):
Orca Biosystems, Inc.

Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoid Leukemia Myelodysplastic Syndromes Acute Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Chronic Myeloid Leukemia, Chronic Phase Biological: Orca-T (formerly TregGraft) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase Ib Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Orca-T (Formerly TregGraft), a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2028

Arm Intervention/treatment
Experimental: Subjects with Acute Leukemia or Myelodysplasic Syndrome, Myelofibrosis, or BPDCN
This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.
Biological: Orca-T (formerly TregGraft)
engineered donor allograft

Primary Outcome Measures :
  1. TregGraft (Orca-T), with single agent GVHD prophylaxis [ Time Frame: 365 days ]

Secondary Outcome Measures :
  1. 1-year overall survival (OS) [ Time Frame: 365 days ]
    1-year overall survival (OS)

  2. 1 year graft-versus-host-disease-free and relapse-free survival (GRFS) [ Time Frame: 365 days ]
    1 year graft-versus-host-disease-free and relapse-free survival (GRFS)

  3. incidence and severity of acute and chronic graft vs host disease (GvHD) [ Time Frame: 365 days ]
    incidence and severity of acute and chronic graft vs host disease (GvHD)

  4. incidence of serious infections [ Time Frame: 365 days ]
    incidence of serious infections

  5. incidence and timing of engraftment [ Time Frame: 28 days ]
    incidence and timing of engraftment of platelets and neutrophils

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 that is not in CR/CRi [Ages 18-65]
    • myelodysplastic syndromes with > 10% to < 20% bone marrow blast burden [Ages 18-65]
    • acute myeloid, lymphoid or mixed phenotype leukemia that is in CR/CRi but is categorized as DRI very high risk [Ages 18-65]
    • Myelofibrosis [Ages 18-65]
    • Blastic Plasmacytoid Dendritic Cell Neoplasm [Ages 18-65]
    • acute myeloid, lymphoid, mixed phenotype leukemia or myelodysplastic syndromes (therapy-related/secondary MDS or eligible for alloHCT per 2017 International Expert Panel) that are in CR and intermediate to high risk per the DRI in patients aged 66 to 75 [Ages 66-75]
    • chronic myeloid leukemia that is in chronic phase with history of blast crisis or accelerated phase and/or is resistant to or intolerant of >1 first- or second-generation TKI [Ages 18-65]
  2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor
  3. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  4. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013685

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Contact: James S McClellan, MD PhD 530-414-9743 info@orcabiosystems.com

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Sponsors and Collaborators
Orca Biosystems, Inc.
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Responsible Party: Orca Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT04013685    
Other Study ID Numbers: Precision-T (PhIb component)
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orca Biosystems, Inc.:
hematopoietic stem cell transplantation
acute leukemia
Myelodysplastic syndromes
matched related donor
matched unrelated donor
Additional relevant MeSH terms:
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Leukemia, Myeloid
Hematologic Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Myeloproliferative Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases