Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Keywords

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Myelofibrosis, Chronic Myeloid Leukemia, Leukemia, Myeloid Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hematologic Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, OrcaGraft (Orca-Q)

Eligibility

You can join if…

Open to people ages 18-65

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

You CAN'T join if...

  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

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • Stanford Health Care accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Orca Biosystems, Inc.
ID
NCT03802695
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 186 study participants
Last Updated