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Trial record 2 of 2 for:    orca biosystems

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

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ClinicalTrials.gov Identifier: NCT04013685
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Orca Biosystems, Inc.

Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("TregGraft", 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 Biological: TregGraft Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase Ib Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With TregGraft, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : November 30, 2022


Arm Intervention/treatment
Experimental: Subjects with Acute Leukemia or Myelodysplasic Syndrome

This is a non-randomized, single-arm study. Patients will be grouped based on their underlying disease:

Group 1 will enroll subjects planning to undergo myeloablative allogeneic hematopoietic cell transplantation (MA-alloHCT) for the treatment of either acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), and with no known minimal residual disease positivity.

Group 2 will enroll subjects Subjects planning to undergo MA-alloHCT for acute myeloid, lymphoid or mixed phenotype leukemia that is either:

  • not in morphologic CR with bone marrow infiltration by leukemic blasts of <= 10%, or
  • in morphologic CR with evidence of minimal residual positivity by either multiparameter flow cytometric analysis or by a nucleic acid-based technique.

Group 3 will enroll subjects planning to MA-alloHCT for high or very high risk myelodysplasic syndrome (MDS) myelodysplastic syndromes.

Biological: TregGraft
engineered donor allograft




Primary Outcome Measures :
  1. The incidence of primary graft failure [ Time Frame: From day of transplant ("Day 0") through day +28 post-transplant ]
    The incidence of primary graft failure

  2. The incidence of Grade III-V acute graft-vs-host disease (GVHD) [ Time Frame: Day 0 through Day +100 ]
    The incidence of Grade III-V acute GVHD


Secondary Outcome Measures :
  1. Timing of Neutrophil engraftment [ Time Frame: Day 0 through Day +28 ]
    Timing of Neutrophil engraftment

  2. Timing of Platelet engraftment [ Time Frame: Day 0 through Day +28 ]
    Timing of Platelet engraftment

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

  4. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Day 0 through Day +365 ]
    Incidence of treatment-emergent adverse events (TEAEs)

  5. Incidence GVHD (all grades) [ Time Frame: Day 0 through Day +100 ]
    Incidence of acute GVHD (all grades)

  6. Incidence of steroid-refractory acute GVHD, including Grade III-IV steroid-refractory acute GVHD [ Time Frame: Day 0 through Day +100 ]
    Incidence of steroid-refractory acute GVHD, including Grade III-IV steroid-refractory acute GVHD

  7. Incidence of chronic GVHD [ Time Frame: Day 0 through Day +365 ]
    Incidence of chronic GVHD

  8. Incidence of Post Transplant Lymphoproliferative Disorder (PTLD) [ Time Frame: Day 0 through Day +365 ]
    Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)

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

  10. Frequency of disease relapse (Arms I and III) [ Time Frame: Day 0 through Day +365 ]
    Frequency of disease relapse (Arms I and III)

  11. GVHD-free and relapse-free survival (GRFS) [ Time Frame: Day 0 to Day +365 ]
    GVHD-free and relapse-free survival (GRFS)

  12. 1 year overall survival (OS) [ Time Frame: Day 0 to Day +365 ]
    1 year overall survival (OS)



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
Criteria

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
  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

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


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

Sponsors and Collaborators
Orca Biosystems, Inc.

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Responsible Party: Orca Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT04013685     History of Changes
Other Study ID Numbers: TRGFT-201
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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