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

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ClinicalTrials.gov Identifier: NCT03802695
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Orca Biosystems, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Acute Leukemia Biological: OrcaGraft Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived From Mobilized Peripheral Blood (OrcaGraft), With Single Agent Graft Versus-host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
Experimental: Related and unrelated HLA-matched donors Biological: OrcaGraft
engineered donor allograft

Experimental: Haploidentical donors Biological: OrcaGraft
engineered donor allograft




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: From day of transplant through day +28 post-transplant ]
    Incidence of dose limiting toxicities (DLTs)

  2. Incidence of primary graft failure [ Time Frame: From day of transplant (Day 0) through day +28 post-transplant ]
    Incidence of primary graft failure


Secondary Outcome Measures :
  1. Incidence and timing of neutrophil engraftment [ Time Frame: Day 0 through Day +28 ]
    Incidence and timing of neutrophil engraftment

  2. Incidence and timing of platelet engraftment [ Time Frame: Day 0 through Day +50 ]
    Incidence and timing of platelet engraftment

  3. Incidence of secondary graft failure through Day +100 [ Time Frame: Day 0 through Day +100 ]
    Incidence of secondary graft failure through Day +100

  4. Treatment-emergent adverse events (TEAEs) through the safety reporting period [ Time Frame: Day 0 through Day +100 ]
    incidence, timing, and severity of TEAEs

  5. Acute graft versus host disease (aGVHD) [ Time Frame: Day 0 through Day +100 ]
    incidence, timing, and severity of aGVHD

  6. Steroid-refractory aGVHD [ Time Frame: Day 0 through Day +100 ]
    Incidence of steroid-refractory acute GVHD

  7. Chronic GVHD (cGVHD) [ Time Frame: Day 0 through Day +365 ]
    incidence, timing, and severity of cGVHD

  8. Post Transplant Lymphoproliferative Disorder (PTLD) [ Time Frame: Day 0 through Day +365 ]
    incidence, timing, and severity of PTLD

  9. Incidence of non-relapse mortality (NRM) [ Time Frame: Day 0 through Day +365 ]
    Incidence of non-relapse mortality (NRM)

  10. Incidence of disease relapse [ Time Frame: Day 0 through Day +365 ]
    Incidence of disease relapse

  11. Disease-free survival (DFS) [ Time Frame: Day 0 through Day +365 ]
    Disease-free survival is the time from date of transplant to death or relapse, whichever comes first

  12. Overall survival [ Time Frame: Day 0 through Day +365 ]
    Overall survival



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03802695


Contacts
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Contact: James S McClellan, MD, PhD 1-530-414-9743 info@orcabiosystems.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: James S McClellan, MD PhD         
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Contact: James S McClellan, MD PhD         
Sponsors and Collaborators
Orca Biosystems, Inc.
Investigators
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Study Director: James S McClellan, MD, PhD Orca Biosystems, Inc.

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Responsible Party: Orca Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT03802695     History of Changes
Other Study ID Numbers: OGFT001-001
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases