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A Phase 1 Study of Engineered Donor Grafts (OrcaGraft/Orca-Q) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802695
Expanded Access Status : Available
First Posted : January 14, 2019
Last Update Posted : October 9, 2020
Information provided by (Responsible Party):
Orca Biosystems, Inc.

Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Acute Leukemia Biological: OrcaGraft (Orca-Q)

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived From Mobilized Peripheral Blood (OrcaGraft/Orca-Q), With Single Agent Graft Versus-host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Intervention Details:
  • Biological: OrcaGraft (Orca-Q)
    engineered donor allograft

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Age ≥ 18 and ≤ 65 years at the time of enrollment
  2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or
  3. High or very high risk myelodysplasic syndrome (MDS) including both of the following:
  4. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
  5. Matched to a related or unrelated donor or to a haploidentical donor
  6. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  7. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  8. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  9. Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 3 times ULN

Key Exclusion Criteria:

  1. 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. Planned donor lymphocyte infusion (DLI)
  4. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  5. Karnofsky performance score < 70% (Appendix 12.7)
  6. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 (Appendix 12.8)
  7. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
  8. Seropositive for HIV-1 or -2, HTLV-1 or -2
  9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  11. History of idiopathic or secondary myelofibrosis
  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 identifier (NCT number): NCT03802695

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Contact: James S McClellan, MD, PhD 1-530-414-9743

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United States, California
City of Hope Available
Duarte, California, United States, 91010
Contact: James S McClellan, MD PhD         
UC Davis Available
Sacramento, California, United States, 95817
Contact: James S McClellan, MD PhD         
Stanford Health Care Available
Stanford, California, United States, 94305
Contact: James S McClellan, MD PhD         
United States, Georgia
Emory University Available
Atlanta, Georgia, United States, 30322
Contact: James S McClellan, MD, PhD         
United States, Kansas
The University of Kansas Hospital Available
Kansas City, Kansas, United States, 66160
Contact: Scott S McClellan, MD, PhD         
United States, Missouri
Washington University Available
Saint Louis, Missouri, United States, 63110
Contact: Scott S McClellan, MD, PhD         
United States, Ohio
Ohio State University Available
Columbus, Ohio, United States, 43210
Contact: James S McClellan, MD, PhD         
United States, Wisconsin
Froedtert Memorial Lutheran Hospital Available
Milwaukee, Wisconsin, United States, 53226
Contact: James S McClellan, MD, PhD         
Sponsors and Collaborators
Orca Biosystems, Inc.
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Study Director: James S McClellan, MD, PhD Orca Biosystems, Inc.
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Responsible Party: Orca Biosystems, Inc. Identifier: NCT03802695    
Other Study ID Numbers: OGFT001-001
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site